Class 4 Medicines Defect Information, Tetralysal 300mg Hard Capsules, (PL 10590/0019), EL (21)A/16

The error 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. Additional warnings, precautions & side effects have been updated in the latest version of the PIL

Source:

Medicines and Healthcare products Regulatory Agency