27 Apr 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
|
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.
Advice to HCPs/Distributors/Public:
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 ).
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.