27 Apr Dopaquel 300mg film-coated tablets (Quetiapine fumarate)
| Company name & Address | registration number | Batch numbers | Expiry date | Pack size | First distributed date. |
Re-call Classification |
Recall date |
|
Dr Reddy’s Laboratories (Pty) Ltd Block B, 204 Rivonia Road Morningside Sandton 2057 South Africa. |
43/2.6.5/0432
|
C2300635 |
11/2025 |
60s |
24 February 2023 |
Class III Type C
|
07 July 2023 |
Reason for recall
Dr Reddy’s Laboratories (Pty) Ltd, in consultation with the SAHPRA has taken a decision to recall Dopaquel 300mg film-coated tablets due to a complaint that was received in the above listed batch with a foreign plastic particle embedded in a broken tablet.
Advice to HCPs/Distributors/Public:
- Distribution and sale of the above-mentioned products should be ceased and immediate quarantine of any units of the above-mentioned batch that they have in their possession and must be returned via their normal distribution channel for full credit.
- Customers are requested to retain the notification letter and place it in a prominent position for one month.
Proposed action taken and its urgency: Any remaining stock is to be quarantined, stock is to be blocked for sale by all distributors. The SAHPRA approved recall letter is to be distributed to all clients and recall process initiated as per recall guideline. The affected batch was only distributed within South Africa.
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.