FDA recall D-1439-2019

Amneal Pharmaceuticals, Inc. · Class III · drug

Product

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

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2017-09-25
Report date: 2019-07-10
Termination date: 2019-08-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1439-2019