Port of Spain, August 18, 2023: The Ministry of Health (MoH), via its Chemistry, Food and Drug Division (CFDD) advises of the voluntary recall of Apo-Amitriptyline 10mg and 25mg and Apo-Acyclovir 200mg, 400mg and 800mg. The recall issued by Apotex Incorporated, the manufacturer of the product, is as a result of exceeded limits for N-Nitroso Nortriptyline (NNORT), which was found in three (3) lots of the drug Apo-Amitriptyline, and the presence of N-Nitrosodimethylamine (NDMA), which was exceeded in five (5) lots of the drug Apo-Acyclovir.
Ultra-Pharm Marketing Limited, the distributor for Apotex products in Trinidad and Tobago, has identified the following batches for recall:
| Product Name | Strength | Size/Format | Lot | Expiry Date |
| Apo- Amitriptyline | 10mg | 1000BTL | PY1833 | December 2023 |
| Apo-Amitriptyline | 25mg | 1000BTL | PV0569 | November 2023 |
| Apo-Acyclovir | 200mg | 100BTL | TE5048 | June 2024 |
| Apo-Acyclovir | 200mg | 100BTL | TK5832 | May 2025 |
| Apo-Acyclovir | 400mg | 100BTL | TH6096 | December 2023 |
| Apo-Acyclovir | 800mg | 100BTL | TK1734 | May 2024 |
| Apo-Acyclovir | 800mg | 100BTL | TK3921 | May 2024 |
The Ministry advises persons who may be in possession of the recalled products with the listed lot numbers and expiration dates, to discontinue use immediately and to return the product to the place of purchase where possible.
Additional Information can be obtained by contacting the Office of the Director of the Chemistry, Food and Drugs Division at 623-5242 or 226-8236, or via email at cfdd@health.gov.tt
The Ministry of Health will continue to monitor the situation and advise the population as necessary.
