Recall: D-1441-2019

Class II - Potentially Harmful

Class IIClassification

2019-05-06Initiated

TerminatedStatus

Zydus Pharmaceuticals USA IncFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.