Drug 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
D-1438-2019
Product summary
- Event
- Event 83137
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19104 units
- Official record key
drug-enforcement:D-1438-2019
Official wording
Reason: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Code information: Lot #: HL05715, HL05815, Exp. 11/2017
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent