Amneal Pharmaceuticals, Inc. recalls Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: A…
- Recall date
- September 25, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1438-2019
- FDA classification
- Class III
- Brand / firm
- Amneal Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
Get recall alerts
Free email alert whenever Amneal Pharmaceuticals, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Amneal Pharmaceuticals, Inc.