Three batches of Tetralysal 300mg Hard Capsules (lymecycline) packs of 56 capsules are circulating with an older version of the patient information leaflet, Galderma has said.
A Class 4 Medicines Defect Information notice issued on July 6th highlights an error with the packaging. “The error identified relates to approved safety-related variations to the PIL that were not implemented, resulting in an older version of artwork being used and packed within finished batches,” said the MHRA.
Additional warnings, precautions and side effects have been updated in the latest version of the PIL, so healthcare professionals are asked to supply an up-to-date PIL if possible when dispensing any of the effected batches.
The affected batches are:
- batch number 853, expiry 07-20203, first distributed February 17 2021
- batch number 869, expiry 12-20203, first distributed May 21 2021
- batch number 881, expiry 03-20203, first distributed May 26 2021
The correct PIL is available from the electronic medicines compendium (emc) at https://www.medicines.org.uk/emc/product/926/pil.