27 Apr 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 |
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).
Advice to HCPs/Distributors/Public:
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.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.