27 Apr Ludiomil 25 mg Film-Coated Tablets (Maprotiline hydrochloride)
| Company name &
Address |
Registration number | Batch number | Expiry date | Pack size | First distributed | Re-call Classification | Re-call Date |
| EQUITY PHARMACEUTICALS (PTY) LTD
Office 1; 100 Sovereign Drive Route 21 Nellmapius Drive |
Section 21 | F0016 | 05/2026 | 100 tablets | August 2024 | Class II Type C | 4.July.2025 |
Reason for recall
This recall is initiated because Equity Pharmaceuticals (Pty) Ltd was informed by the manufacturer that the nitrosamine quantity in the batch mentioned may be above the permitted acceptable daily dose. For this reason, the batch is being recalled as a precautionary measure.
Advice to HCPs/Distributors/Public
We request that you refrain from selling any of the affected batch of Ludiomil 25 mg tablets and return them to your supplying warehouse or distributor with immediate effect. We, Equity Pharmaceuticals, will collect all your stock which will be credited accordingly.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points, and the recall process was 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.