Warning letters, 483s, Recalls, Import Alerts, Audit observations
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
Zydus Pharmaceuticals (USA) Inc initiated recall of multiple lots of Verapamil Hydrochloride injection due to
Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA
Dr.Reddys Laboratories (DRL) has initiated recall of one lot of Allopurinol Tablets, USP 300mg in
Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
In a Class 3 recall Teva initiated recall of one lot each of Nortrel and Nortrel
Sun Pharma initiated recall of several drugs manufactured at Dadra site (India) for cGMP deviation
Hospira Inc., a Pfizer company announced recall of several injectable products in US for potential
FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,
