Wockhardt Again Forced to Recall Thousands of Drugs
Beleaguered Indian generics maker Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers.
The Mumbai-based firm is recalling the drugs after failing to adequately investigate customer complaints, according to FDA enforcement reports. The drugs were manufactured at Wockhardt’s Mumbai facility and distributed by Wockhardt USA.
Included in the recall are 24,496 cartons of amlodipine besylate tablets and 25,357 cartons of lisinopril tablets. Both drugs are used to treat high blood pressure.
Two antibiotics are also being recalled: 5,464 cartons of azithromycin tablets and 3,572 cartons of clarithromycin. Rounding out the recall are 97,837 cartons of famotidine tablets, used to treat ulcers in stomach and intestines, and 5,416 cartons of zonisamide capsules, a seizure treatment.
Wockhardt initiated the Class II recall on June 1.
In May, Wockhardt recalled 93,393 bottles of blood pressure medicine captopril in the U.S. after discovering the tablets failed to meet specification for thickness. And in April, the drugmaker recalled all remaining product from its Waluj and Chikalthana, India, plants due to quality concerns.
Wockhardt did not return a request for comment by press time. — Kellen Owings