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  3. Recall Enforcement Event ID: 83137

Recall Enforment Report D-1438-2019

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Amneal Pharmaceuticals, Inc., originally initiated on 09-25-2017 for the product 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 The product was recalled due to subpotent drug: out of specification assay result in esterified estrogen and methyltestosterone tablets.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1438-201909-25-201707-10-2019Class III19104 unitsEsterified 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 13925-171-01Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.Terminated
D-1439-201909-25-201707-10-2019Class III19176 unitsEsterified 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 13925-172-01Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.Terminated