ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06
Check against the official notice below — it lists the full affected range.
Zydus Pharmaceuticals USA Inc. is recalling Anastrozole 1 mg tablets distributed nationwide due to manufacturing facility cleaning failures that allowed cross-contamination with other products. The recall affects 1,425,264 bottles containing 30 tablets each, manufactured by Cadila Healthcare Ltd. in India, with expiration dates ranging from June 2019 through February 2021. Multiple lot numbers are involved in this recall.
The source document does not specify what consumers should do regarding this recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason for recall: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Distribution: Nationwide in the USA Quantity: 1,425,264 30-count bottles Lot/code info: Lot: M706674, M706676, M707685 EXP Jun-19; M711219, M711220, M711221, M711222, M711269, EXP Sep-19; M801027, EXP Dec-19; M801028, M801029, M801030, EXP Jan-20; M802206, EXP Feb-20, M805195, M805196, M805197, EXP Mar-20; M805199, M805202, M805944, M805945, M805948, M805951, M805953, M805956, M805957, M805958, M805959 Apr-20; M812457, EXP Jul-20, M812458, M812459, M813912, M813913, M813914, M813915, M813916, EXP Aug-20; M815768, M815769, M818274, EXP Oct-20; M818119, M818120, M818121, M818635, EXP Nov-20; M819270, M819861, M819862, EXP Dec-20; M900921, M900922, M900923, M900924, M900925, EXP Jan-21; M902634, M902635, EXP Feb-21.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.