Class III
Terminated
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
- Company
- Amneal Pharmaceuticals, Inc.
- Recall Initiated
- September 25, 2017
- Posted
- July 10, 2019
- Recall Number
- D-1438-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 19104 units
- Firm Location
- Brookhaven, NY, United States
Reason for Recall
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: HL05715, HL05815, Exp. 11/2017
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