FDAClass IIJune 26, 2019

ANASTROZOLE Tablets recall: CGMP Deviations

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

Why was ANASTROZOLE Tablets recalled?

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
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
Recalling firm
Zydus Pharmaceuticals USA Inc
Quantity
1,425,264 30-count bottles
Distribution
Nationwide in the USA
Recall date
June 26, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls