US Drug Recall Register
Class III · Low risk Terminated Initiated Sep 25, 2017 (9 years ago)

Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

What was recalled

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

Recalling firm
Amneal Pharmaceuticals, Inc.
NDC code
13925-171-01
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1438-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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