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
Reported: July 10, 2019 Initiated: September 25, 2017 #D-1439-2019
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.
Details
- Recalling Firm
- Amneal Pharmaceuticals, Inc.
- Units Affected
- 19176 units
- Distribution
- Nationwide within the United States
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amneal Pharmaceuticals, Inc.. Units affected: 19176 units.
Why was this product recalled? ▼
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 10, 2019. Severity: Low. Recall number: D-1439-2019.
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