Reported Jul 10, 2019 · Terminated
Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by:…
Amneal Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals, Inc. · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
- Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only
- Manufactured byAmmeal Pharmaceuticals of NY Hauppauge
- NY 11788 Distributed by
Seton Pharmaceuticals ManasquanNJ 08736NDC 13925-172-01
- Lot codes and dates
Lot #: HL06015HL06115Exp. 10/2017
- Amount recalled
- 19176 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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