Product Recalls

1. Champix 0,5 mg and 1,0 mg (varenicline) film coated Tablets - combo

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

2. ZAARIO 50 and ZAARIO 100 film coated Tablets (lorsatan potassium)

 

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.

3. Clonam 0.5 mg and Clonam 2 mg film coated Tablets (clonazepam)

 

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.

4. Panado 500mg Tablets (paracetamol)

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.

5. Adco-Napamol Tablets (paracetamol)

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.

6. Zyklot 75, tablets (clopidogrel)

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.

7. Zartan Co 50/12,5 and Zartan Co 100/25 film coated Tablets (lorsatan potassium/ hydrochlorothiazide)

 

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.

8. Co-Irbewin 300/12.5 mg, Tablets (Irbersatan &hydrochlorothiazide) and Irbewin 150 mg Tablets (irbersatan)

 

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.

9. LOSAAR PLUS 50/12.5 TABLETS 30'S (losartan 50 mg, hydrochlorothiazide 12,5 mg) and LOSAAR PLUS 100/25 TABLETS 30'S (losartan 100 mg, hydrochlorothiazide 25 mg)

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.

10. Azacitidine DRL 100mg Lyophilized powder for Injection (Azacitidine)

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.

11. DERMADINE ORAL ANTISEPTIC solution (Povidone-iodine 1,00 g (1 % m/v))

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.

12. OsvaRen 435mg_235 film coated tablets

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.

13. Oranix Solution (oral rinse) (Benzydamine HCl 22,5 mg/15 ml; Chlorhexidine gluconate 18,0 mg/15 ml)

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

15. Lactulose concentrate API (Lactulose Concentrate solution- 66% and 70% )

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.

16. PROTA 50 mg/ 5 ml (Protamine Sulphate - Ampoules for IV injection)

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.

17. Accumax 10mg and 20 mg Film Coated Tablet (QUINAPRIL HYDROCHLORIDE)

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 ).

18. Demetrin 10mg (prazepam)

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.

19. Coryx Throat Spray (Benzocaine and chlorhexidine gluconate solution 20 %).

Company name & Address:  

registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First date of release

 

Re-call Classification

 

Re-call Date

 

Cipla Medpro (Pty) Ltd

 

Parc du Cap

Building 9

Mispel Street

Bellville

7530

Telephone number (021) 94
 

 

 W/16.3/58
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

20. Adco-Napacod tablets (Paracetamol 500 mg and Codeine Phosphate 10mg)

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.

21. Rocephin 1G injection (1 vial with dry substance equivalent to 1g ceftriaxone + 1 ampoule water for injection 10ml)

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.

22. JANUMET 50/850mg and JANUMET 50/1000mg (50mg of Sitagliptin with 850mg of Metformin Hydrochloride AND 50mg of Sitagliptin with 1000mg of Metformin Hydrochloride)

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:

  1. The incorrect artwork for both the packaging insert and the unit carton. The languages are in English and Portuguese and should be in English and Afrikaans per the local market requirements.
  2. The packs do not contain a Patient Information Leaflet.
  3. The material for the primary packaging is not registered for the local market.
  4. The sold packs do not have the SA registration on the artwork

 

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

23. Vitaforce Schlehen Blackthorn Berry Elixir (Ascorbic acid (Vit C) 33,5 mg)

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.

24. Austell Azithromycin (Azithromycin 200 mg/5 ml powder for suspension)

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.