Home / Recalls / Amneal Pharmaceuticals, Inc. / D-1438-2019

D-1438-2019 Class III Terminated

Recalled by Amneal Pharmaceuticals, Inc. — Brookhaven, NY

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
19104 units

Product Description

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

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 #: HL05715, HL05815, Exp. 11/2017

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