Recalls / Class III
Class IIID-1438-2019
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
- Affected lot / code info
- Lot #: HL05715, HL05815, Exp. 11/2017
Why it was recalled
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Recalling firm
- Firm
- Amneal Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 19104 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2017-09-25
- FDA classified
- 2019-07-01
- Posted by FDA
- 2019-07-10
- Terminated
- 2019-08-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1438-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.