FDA-Drug2019-07-10Class III
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
Amneal Pharmaceuticals, Inc.
Hazard
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Sold states
Nationwide within the United States
Affected count
19104 units
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1438-2019Don't want to check this manually?
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