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
Recall Number: D-1438-2019
Firm: Amneal Pharmaceuticals, Inc.
Classification: Class III
Status: Terminated
Report Date: 20190710
Initiation Date: 20170925
Termination Date: 20190808
Reason for Recall
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Product Description
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