Drug recall D-1441-2019

Class II Terminated reported Jun 26, 2019

Product

Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10

Reason for recall

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

Lots and codes

Lot EXP Date: M708570 Jun-19, M711270 Sep-19, M802207 Feb-20, M812460 Aug-20

Recall details

Recalling firm
Zydus Pharmaceuticals USA Inc, Pennington, NJ
Quantity
768 1000-count bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
May 6, 2019
Terminated
September 16, 2021

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