ANASTROZOLE Tablets recalled over manufacturing violations
- Recall date
- May 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Zydus Pharmaceuticals USA Inc recalls ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distribu…
- Recall number
- D-1440-2019
- FDA classification
- Class II
- Brand / firm
- Zydus Pharmaceuticals USA Inc
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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