According to the US FDA’s latest enforcement report, the recall was initiated after black spots were found on the tablets due to burnt excipient used for manufacturing.
New Delhi: Sun Pharmaceutical Industries is undertaking a voluntary recall of “1968 bottles” anticonvulsant therapy, “carbamazepine” in the US.
According to the US FDA’s latest enforcement report, the recall was initiated after black spots were found on the tablets due to burnt excipient used for manufacturing.
Sun Pharma initiated the recall on August 3 following a complaint about black specks found in tablets. The company later identified cGMP deviations as the underlying cause of the issue.
The affected batch was manufactured at Taro Pharmaceutical’s (wholly-owned subsidiary of Sun Pharma) Haifa Bay-based facility in israel.
Carbamazepine is an anti-seizure therapy which is used to treat epilepsy, nerve pain like trigeminal neuralgia, and bipolar disorders.
The nationwide rollback is classified as a “call II” recall by the FDA, meaning that the products may cause temporary or reversible adverse health consequences. However the probability of serious adverse health consequences is remote.
