27 Apr Lancap 15mg capsules (Lansoprazole)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Recall date
|
| Pharma Dynamics (Pty) Ltd Floor 1, Grapevine House. Steenberg Office park, Silverwood close, Westlake, Cape Town, South Africa 7945 |
A40/11.4.3/0247 |
SJ2758 SJ3425 SJ2652 SJ8693 |
Mar 2024 Nov 2023 Mar 2024 Aug 2024 |
14’s
|
10.Sep.2021 22.Sept.2021 13.Sept.2021 15.Mar.2022 |
Class III Type C
|
12.Sep.2022 |
Reason for recall
This recall is initiated due to detection of non-conformances to the Medicines and Related Substances Act (Act 101 of 1965), in terms of the printed packaging material packaging material of LANCAP 15 mg (14 capsules): The schedule as per the carton [S4] does not align to the consolidated schedules, in that a product containing 15 mg of Lansoprazole as a maximum daily dose and for a maximum treatment period of 14 days is indicated under S2. The indication per the carton (for the relief of heartburn and hyperacidity) is in line with S2 of the consolidated schedules, however this does not align with the S4 scheduling included on the carton.
Advice to HCPs/Distributors/Public:
The company requested their clients to quarantine, refrain from selling and to return all inventory of LANCAP 15 mg (14 capsules), [S4] medication to their relevant distributor and/or wholesaler with immediate effect for reimbursement.
Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated.
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.