D-1439-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 10, 2019
- Initiation Date
- September 25, 2017
- Termination Date
- August 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19176 units
Product Description
Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
Reason for Recall
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: HL06015, HL06115, Exp. 10/2017