Amneal Pharmaceuticals, Inc. recalls Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: A
Recalled July 10, 2019 · FDA recall D-1438-2019 · Amneal Pharmaceuticals
Hazard
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. · FDA Class III
Units
19104 units
Sold at
Nationwide within the United States
Description
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Product
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
Manufacturer(s)
Amneal Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →