Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton South
Africa |
41/34/0573- 41/34/0572 |
18069 |
31Aug-2021 |
Starter Pack 0.5mg/1mg Film Coated Tablet 1×11+3×14 |
12 Apr-2019 |
Class III Type B |
19 August 2021 |
Brief description of the problem (reason for recall)
Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily Intake (ADI) threshold of 733 ng/day calculated by Pfizer, based on ICH M7 guidance, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Champix, batch 18069 and notified SAHPRA Regulatory Compliance Units. Recall process: Recall letter distributed to all healthcare professionals via medpages.
Advise for health professionals and distributors:
The company requested the immediate return of all the affected batch of Champix to the supplying distributor for full credit without delay. As a precautionary measure, distribution remains on hold of all Distribution Points under Pfizer control
Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
UNICORN PHARMACEUTICALS (PTY) LTD
CNR SEARLE AND PONTAC STREETS, CAPE TOWN, 8001 |
50 mg: 46/7.1.3/0714 |
LS220001A |
July-2022 |
30 |
12/11/2020 |
Class II Type B |
31 August 2021 |
100 mg: 46/7.1.3/0715 |
LS320002A |
June-2022 |
30 |
30/11/2020 |
Class II Type B |
31 August 2021 |
Brief description of the problem (reason for recall)
The products are being recalled due to quality defect: the presence of a mutagenic impurity above the threshold limit observed during analysis, as requested by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on new Azido impurities [the presence of Azido (5-AMBBT) mutagesic impurity beyond total threshold limit was observed during analysis].
Advise for health professionals and distributors:
Stock is blocked for distribution and immediate quarantine of stock is initiated in Distribution and Wholesales. Quantity of stock affected to be confirmed. Return any of the above products to your United Pharmaceutical Distributor (UPD) wholesaler.
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Ascendis Health Ltd 31 Georgian Crescent East Bryanston, South Africa |
0.5 mg: 45/2.5/0820 |
7862006-8 (3 batches) |
July-2022 |
84’s (Carton with Blister) |
12.July.2019 |
Class II Type B |
20 September 2021 |
2 mg: 45/2.5/0821 |
7872005-6 (2 batches) |
June-2022, July- 2022 |
84’s (Carton with Blister) |
12.July.2020 |
Class II Type B |
20 September 2021 |
*CLONAM 0.5mg and CLONAM 2 mg are both on state tender, code: RT289-2019, tender numbers: 51401516-00002 & 51401516-00001.
Brief description of the problem (reason for recall)
The products are being recalled due to quality defect: the tablet description should be cross-scored, but instead the tablet has only a single score.
Advise for health professionals and distributors:
All remaining stock at distributor put in quarantine to avoid sale and to prevent further stock from being distributed. Customers/ health professionals were sent a recall letter and feedback was requested regarding quantity of stock on hand. Available stock at customers to be returned and placed in quarantine.
Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Adcock Ingram limited – 1 New road, Midrand 1685, South Africa |
B/2.8/858 |
AC1696 |
Sept-2022 |
24 |
11/2020 |
Class II Type B |
13 July 2021 |
Brief description of the problem (reason for recall)
The product was being recalled due to quality defect: Discoloration of tablets found in the batch.
Advise for health professionals and distributors:
The identified batches blocked for sale at Adcock Distribution centers and Hold Notification letter for Adco-Napamol tablets 5000’s was circulated to the Distributors and Wholesalers who bought directly from Adcock DCs. All stock of this batch must be immediately returned to your supplying wholesaler or distributor for full credit.
Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Adcock Ingram limited – 1 New road, Midrand 1685, South Africa |
B/2.7/1404 |
AC1369, AC1373, AC1441, AC1430 |
07/2022; 08/2022 |
5000’s |
Dec 2020 |
Class II Type B |
13 July 2021 |
Brief description of the problem (reason for recall)
The product was being recalled due to quality defect: Discoloration of tablets found in the batch.
Advise for health professionals and distributors:
The identified batches blocked for sale at Adcock Distribution centers and Hold Notification letter for Adco-Napamol tablets 5000’s was circulated to the Distributors and Wholesalers who bought directly from Adcock DCs. All stock of this batch must be immediately returned to your supplying wholesaler or distributor for full credit.
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Zydus Healthcare SA (Pty) Ltd, Southdowns Office Park, 22 Karee Street, Centurion, 0157, Pretoria
South Africa. |
A46/8.2/0972 |
M912323 AND M000240 |
31/07/2021(M912323) and 30/11/2021(M000240) |
30 |
12/11/2020 |
Class II Type B |
20 May 2021 |
Brief description of the problem (reason for recall)
Austell Pharmaceuticals took the decision to initiate a voluntary recall on Azithromycin 200 mg/5 ml Powder for suspension. The recall is to be instituted due to some of the containers having defective primary packaging resulting in the seal being discoloured, which is not in line with the product specifications.
Advise for health professionals and distributors:
The company requested immediate return of all units on hand of the batches mentioned above to their supplying wholesaler or distributor for a full credit.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all distribution points, recall initiated.
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Pharma Dynamics (Pty) Ltd
Grapevine House, Steenberg Office Park, Silverwood, WestLake Cape Town South Africa |
42/7.1.3/1068, |
LC60922, LC60925, LC60717, LC60718, LC60716 |
August/2023 |
30 |
11 June 2021 |
Class II Type B |
15 September 2021 |
42/7.1.3/1069 |
LC60719, LC60721, LC60722 |
August/2023 | 30 | 02 July 2021 |
Class II Type B |
15 September 2021 |
Brief description of the problem (reason for recall)
The products are being recalled due to quality defect: Presence of mutagesic azide impurity: The impurity, also known as known as 4-chloro azido methyl tetrazole, was detected during routine assessment and is formed during the manufacture of the active ingredient (API). The confirmed presence of a potential new azide impurity via their manufacturer was communicated to the API supplier (Zheijang Tianyu Pharmaceutical company).
Advise for health professionals and distributors:
As a precautionary measure all batches have been blocked for sale and immediate quarantine of stock is initiated in Distribution and Wholesales. Healthcare professionals are urged to return all inventory of ZARTAN CO 50/12,5 and ZARTAN CO 100/25 to their relevant distributor and/or wholesaler as soon as possible for reimbursement. Please retain this letter in a prominent position for at least one month in case of stock in transit.
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Sanofi-Aventis South Africa, 2 Bond Street Grand Central Ext. 01 Midrand 1685. |
40/7.1.3/0287 |
AA550, AA507 |
August 2023 |
30 |
28 May 2020 |
Class II Type B |
27 October 2021 |
40/7.1.3/0288 |
AA406 |
September 2023 |
30 |
12 February 2021 |
Class II Type B |
27 October 2021 |
Brief description of the problem (reason for recall)
These products are being recalled due to quality defect: Presence of impurity, also known as GTI 2 (5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole – CAS 152708-24-2) is formed during the manufacture of the active ingredient.
Advise for health professionals and distributors:
Stock is blocked for distribution and immediate quarantine of stock is initiated.
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Accord Healthcare (Pty) Ltd, Building 2, Tuscany Office Park 6 Coombe Place, Johannesburg, South Africa |
50/12.5mg: 42/7.1.3/0325 |
01523, 000919, 000920, 01870 |
May 2023 Jul 2023 |
30 |
July 2020 |
Class II Type B |
6 October 2021 |
100/25 mg:
46/7.1.3/0715 |
00915, 00916,
00917, 00918 |
May-2023 | 30 | July 2020 | Class II Type B | 6 October 2021 |
Brief description of the problem (reason for recall)
The products are being recalled due to quality defect: The company initiated an immediate recall of the following batches of the products, as listed above, following the detection of an azido impurity in the losartan active ingredient. The impurity, also known as 4-chloro azido methyl tetrazole is formed during the manufacture of the active ingredient.
Advise for health professionals and distributors:
Healthcare professionals are urged to return all stock on hand of the above batches of LOSAAR PLUS 50/12,5 and LOSAAR PLUS 100/25 to their relevant distributor and/or wholesaler as soon as possible for reimbursement. Please retain this letter in a prominent position for at least one month in case of stock in transit.
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Dr. Reddy’s Laboratories Limited, Chemical Technical Operations, Unit- I, Plot No. 137,138, 145
& 146 |
51/26/0144 |
H210418 |
Mar/2023 |
Vial: 30ml |
2021/10/06 |
Class III Type C |
11 January 2022 |
Brief description of the problem (reason for recall)
The products are being recalled due to quality defect: The company initiates an immediate recall of the following batches of the products, as listed above, following detection during periodic re-qualification of VHP (Vaporized Hydrogen Peroxide) decontamination cycle executed at Dr. Reddy’s Formulation Unit-07, for the Filling Isolator Equipment PR-E235 & PR-E3 l 8 (Zone 1 + 3) in Line-1, Biological Indicator (BI) failure observed at locations pertaining to ISl0- Lyo loading & unloading area. Root Cause: From the investigation it was concluded that the failure of VHP requalification run was due to improper distribution of the vaporized hydrogen peroxide vapours inside the isolator. The probable reason for the failure was due to the presence of polybags in the VHP distribution lines of Isolator IS10.
Advise for health professionals and distributors:
The action was initiated to halt and facilitate return of any potential product available at wholesale level. Distribution points will be requested to return the impacted product via their routine distribution channel to receive credit for the relevant quantities returned. All product impacted in South Africa was quarantined at the warehouse facility and reconciled against the quantity distributed.
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Cipla Medpro (Pty) Ltd, Cipla Head Office, Parc du Cap, Building 9, Mispel Street, Bellville, Bellville,Cape Town, 7530, South Africa |
H1511 (Act 101/1965) |
120983 |
October 2022 |
200 ml |
September /2020 |
Class III Type C |
24 January 2022 |
Brief description of the problem (reason for recall)
This product is being recalled due to a complaint relating to quality defect: The impacted batch of Dermadine Oral antiseptic solution was deemed to be defective and did not comply with the requirements of Act 101 of 1965 in terms of the product specification, Solution is clear – no iodine colour, smell or taste, (lack of efficacy).
Advise for health professionals and distributors:
Please refrain from selling or dispensing this batch. Stock of the affected the batch is re-called from the wholesalers and direct retailers, including cross- border customers, utilising company representatives.
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Fresenius Medical Care South Africa (PTY) Ltd. 9 Galaxy Ave. Frankenwald Sandton 2090, South Africa |
45/24/0919 |
ZC015 200, ZOAK08100, ZOAK04 200, ZC016100, ZOAK04300, ZOAK05200, ZOAK08300 |
2.2021 (old), 30.07.2022 (new) 9.2021 (old), 31.07.2022 (new) 2.2021 (old),12.20 21 (new) |
180s |
04/10/2019 |
Class III Type B |
22 April 2022 |
Brief description of the problem (reason for recall)
This product is being recalled due to a complaint relating to quality defect: Complaint on the final product packaging of Osvaren 435mg/ 235m g film- coated tablets (a secondary label with new expiry date affixed on top of the originally printed one).
Advise for health professionals and distributors:
Immediate batch tracing, quarantine of stock from all distributors & their clients, immediate notification to recall the batches sent to the regulatory authority.
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
iNova Pharmaceuticals (Pty) Ltd
15E Riley Road, Bedfordview, 2007 South Africa |
34/16.4/0391 |
126189 |
11/2023 |
200 ml |
13.12.2021 |
Class III Type C |
28 January 2022 |
Brief description of the problem (reason for recall)
This product is being recalled due to a complaint relating to quality defect: The assay of the active pharmaceutical ingredient, chlorhexidine gluconate, is below approved specification and the efficacy of this product cannot be guaranteed, (Assay limit of Chlorhexidine Gluconate ut of specification).
Advise for health professionals and distributors:
Immediate batch tracing, quarantine of stock from all distributors & their clients, immediate notification to recall the batches
Manufacturer name
& Address |
Customers |
Batch number |
Manufacturing Date |
Expiry dates |
Batch release date |
Quantity dispatched to customer |
Re-call Classification |
Re-call Date |
Lacsa (Pty) Limited
72 Ballantrae Road, Merebank, Durban, South Africa |
Pharmchem Lab | P3915 | 17.Sept.2021 | 11Aug-2025 | 24.Aug.2021 | 840 kg | Class II Type B | 18 May 2022 |
Relax Limited | P3822, P3823,
P3841, P3912,P3913 P3915, P3916,P3919, |
11.Jan.2021,
13.Jan.2021, 31.Oct.2020, 07.Aug.2021, 11.Aug.2021 |
10.Jan.2025,
13.Jan.2025 31.Oct.2024 07.Aug.2025 13.Aug.2025 |
25.Jan.2021
08.Feb.2021 11.Mar.2021 30.Aug.2021 24.Aug.2021 |
696 060 kg | Class II Type B | 18 May 2022 |
Brief description of the problem (reason for recall)
The product was being recalled due to quality defect:The product was found to have microbial counts with yeast (Millerozyma farinose) and mould; the count was above specification. Out of Specification results were then reported by customer whilst using customer method (undiluted), which was confirmed by the manufacturer using customer method. The recall was requested based on the presence and count of the organism.
Recall process: Recall letters have been distributed to all Distributors.
Advise for health professionals and distributors:
The manufacturer requested for the immediate return of all the affected batches of Lactulose concentrate API to the supplying distributor without delay. As a precautionary measure, distribution remains on hold for all stock on site at the manufacturer and no manufacturing is taking place until corrective measures are confirmed.
Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Equity Pharmaceutica ls (Pty) Ltd, 100 Sovereign Drive, Route 21 Corporate park, Irene, Pretoria, South Africa, 0157 |
N/A (Section 21, Unregistered) |
IPTAA1203 | 31.12.2023 | 25’s |
11/2020 |
Class II Type B |
26 May 2022 |
Brief description of the problem (reason for recall)
The product was being recalled due to quality defect: Floaters that look like mould were found inside a few number of ampoules.
Advise for health professionals and distributors:
As a safety precautionary measure, due to affected units found, Equity Pharmaceuticals (Pty) Ltd recommends that healthcare providers should immediately discontinue the use of PROTA injection and to return all units of PROTA to Equity Pharmaceuticals (Pty) Ltd. and send an email to section21@equitypharma.co.za to arrange for upliftment and credit. They are also advised to retain the recall letter in a prominent position for one month.
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Pfizer Laboratories (Pty) Ltd
85 Bute Lane, Sandton, South Africa |
34/7.1.3/0230 |
CK8048, DC6880 and DM5063 |
28/02/2022 |
30s 10 mg |
19-Oct-2019
30-Mar-2020
10-Jun-2020 |
Class II Type B |
25 April 2022 |
Pfizer Laboratories (Pty) Ltd
85 Bute Lane, Sandton, South Africa |
34/7.1.3/0231 | DM5060,
EA7796 and, |
31/12/2022
|
30s 20 mg | 20-May-20,
28-Sep-20
24-Jan-20 |
Class II Type B | 25 April 2022 |
AW1957, CM2638
|
28/02/2022 | 24-Jan-20
|
Brief description of the problem (reason for recall)
This product is being recalled due to a quality defect: N-Nitroso-quinapril was detected in Accumax batches tested to be above the Acceptable Daily Intake. According to the Applicant, the nitrosamine (N-Nitroso-quinapril) detected in this product is a newly identified one.
The acceptable daily intake limit (AI) calculated should be 18 ng/day.
Advise for health professionals and distributors:
An Immediate batch tracing, quarantine of stock from all distributors & their clients was conducted. Also, an immediate notification to recall the batches was sent to the regulatory Authority (SAHPRA). A recall letter was distributed to all healthcare professionals via medpages.
Customers were advised, in a form of a recall letter, to return the units of the batches listed in the table to their supplying distributor/wholesaler for full credit without delay.
For further product information or medical queries, please address this to: Pfizer’s Medical Information on 0860 734 937 (or email at Med.Info2@Pfizer.com ).
Company name & Address | Registration number | Batch number | Expiry date | Pack size | First distributed |
Re-call Classification |
Re-call Date |
Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton South Africa |
G/2.6/188 |
DT3236 |
28 Feb-2023 |
100’s |
21 July-2020 |
Class II Type B
|
4 July 2022 |
Brief description of the problem (reason for recall)
The recall is due to out of specification results for dissolution during stability studies, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Demetrin 10 mg, batch DT3236.
Advise for health professionals and distributors:
The company requested the return of all stock of the affected batch to the supplying distributor/wholesaler for full credit without delay.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall initiated.
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Re-call Date |
||||||||
|
|
ZB000156,
ZB000157, ZB000158, ZB000159, ZB000160, ZB100105, ZB100107 ZB100172
|
10.2022
10.2022 10.2022 10.2022 10.2022 02.2023 02.2023 03.2023 |
100 ml |
04.02.2021
04.02.2021 09.02.2021 09.02.2021 09.02.2021 14 & 15.06.2021
21. 06.2021 |
Class I Type A
|
15 June 2022 |
Brief description of the problem (reason for recall)
Cipla Medpro (Pty) Ltd, in collaboration with SAHPRA, is recalling the above-mentioned batches of Coryx Throat Spray.
The reason for the Class I Type A product recall is the remote possibility that the spray nozzle may detach from the spray mechanism during use:
The company received two product complaints from two customers (1st customer on 04.06.2021 & 2nd customer on 06.12.2021) who purchased a bottle of Coryx Throat Spray.
Customer 1: The customer complained that the spray nozzle came off and was stuck in his throat, he was not able to remove it and the cap was swallowed. The customer further explained that his throat was damaged trying to remove the cap.
Customer 2: The customer complained that the spray nozzle of the bottle came off while he was using it and he involuntarily swallowed it.
Advise for health professionals and distributors:
All affected stock/ batches should be removed from the client’s inventory with immediate effect and returned via the normal distribution channel. The recall applies to all distribution points i.e. wholesalers throughout the country, hospital services (private as well as state hospitals), retail outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers and individual customers or patients.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all the above-mentioned distribution points and an approved press statement released to public. Immediate recall has been initiated.
Media release Publication: eNCA Headline: Cipla recalls batches of Coryx throat spray
Link: https://www.enca.com/business/cipla-recalls-batches-coryx-throat-spray
Media Coverage confirmation: Coryx Throat recall
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Adcock Ingram Limited.
1 New Road, Midrand, 1685 |
B/2.8/1401 |
AD0433
AC1264 |
02-2026
06-2025 |
1000’s |
25 June-2021
08 Oct-2020 |
Class II Type B |
23 June 2022 |
Brief description of the problem (reason for recall)
The products are being recalled due to quality defect: the company received customer complaints reporting discoloration of tablets and/or discoloured silica gel (complaints were either about discoloured silica gel sachets only or discoloured silica gel sachets and tablets with which the sachets had direct contact).
Advise for health professionals and distributors:
Affected stock has been blocked for distribution and the product placed on hold at Adcock Ingram distribution centers.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall Initiated.
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
Roche products (Pty) LtdBuilding E, Hertford Office Park90 Bekker Road, Midrand
1686 |
R/20.1.1/46 |
B0757B04
|
31-03-2024 |
1 |
Mar-2021
|
Class I Type C |
1 July 2022 |
Brief description of the problem (reason for recall)
The products are being recalled due to quality defect: Pinholes were found on the 10ml Water for Injection that is co-packaged with the Rocephin 1g Vial. These pinholes are melting defects located at the top of the ampoule head and surrounded by concavity.
Advise for health professionals and distributors:
Affected stock has been blocked for distribution and the applicant requested their clients for immediate return of the affected batch of Rocephin 1G Vial pack to the
supplying wholesaler or distributor for full credit.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall Initiated.
Company name & Address: |
Product |
registration number |
Batch number(s) |
Expiry date(s) |
Pack size |
|
Re-call Classification |
Recall date |
117, 16th Road, Midrand, South AfricaPrivate Bag 3, Halfway House, 1685 |
JANUMET 50/850mg
|
42/21.2/1090 |
W01552
W01553 |
2023/10/31
2023/10/31
2023/10/31
|
28s
28s |
2022/07/06
2022/07/18 |
Class III Type C
|
05.Sept.2022
|
JANUMET 50/1000mg |
42/21.2/1091 |
W015798 | 2023/11/30 | 28s | 2022/07/18
|
Class III Type C |
05.Sept.2022 |
|
W015803 | 2023/11/30 | 28s | 2022/07/06
|
|||||
W017752 | 2023/11/30 | 28s | 2022/07/27
|
|||||
W018077 | 2023/11/30 | 28s | 2022/08/02
|
|||||
W021662 | 2024/01/31 | 28s | 2022/08/12 |
Brief description of the problem (reason for recall)
The products are being re-called due to quality defect; the company initiated a recall because the above batches are not in compliance with the registered requirements for the South African market, as follows:
Advise for health professionals and distributors:
The company has requested the customers to refrain from selling any of the affected batch(s) of the JANUMET 50/850 mg and 50/1000mg packs and return to them to their supplying warehouse / distributor with immediate effect.
Proposed action taken and its urgency: The recall has id initiated; a SAHPRA approved recall letter to be distributed to all distribution points
Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
Re-call Classification |
Recall date |
Ascendis Consumer Brands (Pty) Ltd, 1 Carey Street, Wynberg, Sandton, Gauteng |
N/A (Category D product) |
151717 151848 151725 151844 152003
|
BatchNo:151717 Exp date:12/2024 Batch No:151848 Exp Date 02/2025 Batch No:151725 Exp Date: 02/2025 Batch No: 151844 Exp Date:03/2025 Batch No:152003 Exp Date 05/2025 |
200 ml and 500 ml
|
Class III Type C
|
09.Sept.2022 |
Brief description of the problem (reason for recall)
The products are being re-called due to quality defect: The company received a complaint from a customer who indicated that the product is foamy and smells fermented.
Advise for health professionals and distributors:
Affected stock has been blocked for distribution and the applicant requested their clients for immediate return of the affected batch.
Proposed action taken and its urgency: The recall is initiated; a SAHPRA approved recall letter to be distributed to all distribution points.
Company name & Address | Registration number | Batch number | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
Austell Pharmaceuticals 1 Sherborne Road Parktown 2193, South Africa |
A50/20.1.1/0567 |
MG22413 MG22414
MG22415 |
04/2027 04/2027 05/2027 |
15 ml | 11/07/2022 | Class III Type C |
29.Sept. 2022 |
Brief description of the problem (reason for recall)
Austell Pharmaceuticals took the decision to initiate a voluntary recall on Azithromycin 200 mg/5 ml Powder for suspension. The recall is instituted due to some of the containers having defective primary packaging resulting in the seal being discoloured, which is not in line with the product specifications.
Advise for health professionals and distributors:
The company requested immediate return of all units on hand of the batches mentioned above to their supplying wholesaler or distributor for a full credit.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all distribution points, recall initiated.
Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
iNova Pharmaceuticals (Pty) Ltd 15E Riley Road, Bedfordview, 2007
|
33/16.4/0285
|
126355
127226
|
02/2025 04/2025
|
10 g tube |
Batch 126355: 08/04/2022 Batch 127226: 26/05/2022 |
Class III Type C
|
07.Oct.2022 |
Brief description of the problem (reason for recall)
iNova Pharmaceuticals took the decision to initiate a voluntary recall on Andolex-C Oral Gel. The recall is instituted due to Stability data assessed at 3 and 6 months which showed an out of specification result on microbiological growth on both batches and the assay value of Cetylpyridinium Chloride which tested below approved limits for batch 127226.
Advise for health professionals and distributors:
The company requested immediate blockage of stock on hand of the batches mentioned above, and for the distributors to be in contact with their customers who purchased the affected stock.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
Viatris South Africa (Pty) Ltd 4 Brewery Street Isando, Gauteng, 1609
|
45/7.1.3/0607 |
8130141
|
10/2024
|
30s |
08/03/2022 |
Class II Type B
|
10.Oct.2022 |
Brief description of the problem (reason for recall)
Viatris South Africa (Pty) Ltd took the decision to initiate a voluntary recall on Mizart 80 mg tablets. This recall is initiated in view of a complaint received, regarding comingling of tablets in a securi-tainer of Mizart 80 mg (30’s).
Advise for health professionals and distr
The company requested customers to refrain from selling Mizart 80mg tablets of the affected batch (batch nr. 8130141) and return it to their supplying warehouse or distributor with immediate effect. The applicant confirmed that they will ensure that the stock of batch 8130141 is replaced to their customers.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
Sanofi Aventis South Africa (Pty) Ltd/Zentiva Pharmaceuticals (Pty) Ltd 5th Floor Building I Hertford Office Park 90 Bekker Road Vorna Valley, Midrand
|
V/18.1/9 |
CG022A |
12/2023 |
30s |
22/04/2022 |
Class II Type C
|
17.Oct.2022 |
Brief description of the problem (reason for recall)
Sanofi Aventis South Africa (Pty) Ltd took the decision to initiate a voluntary recall on Lasix tablets 80 mg. The recall is instituted following the detection of a dissolution failure at the 6 months testing interval. The results for dissolution were below the required 80% after 60 minutes.
Advise for health professionals and distributors:
The company requests and urges their customers to return all stock on hand of Lasix 80mg tablets 30s, batch: CG022A to their relevant distributor and/or wholesaler as soon as possible for reimbursement.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
Zydus Healthcare SA (Pty) Ltd. Southdowns Office Park, 22 Karee Street, Centurion, 0157
|
4/10.2.2/0792 |
108011 |
31/05/2024
|
30s |
30/08/2021 |
Class II Type B
|
17.Oct.2022 |
Brief description of the problem (reason for recall)
Zydus Healthcare SA (Pty) Ltd took the decision to initiate a voluntary recall on Lumont 10 mg tablets. The recall is instituted due to out of specification results observed in dissolution test at 12 Month(s) time point interval in long term condition i.e., 30°C/75% RH.
Advise for health professionals and distributors:
The company requests all customers to refrain from selling or dispensing stock from the affected batch. Undistributed stock on hand placed on quarantine with immediate effect. All affected returned stock will be replaced free of charge.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.