The Recall Desk

FDA (Drugs) recall action 83137

Amneal Pharmaceuticals, Inc. recalled 2 products on 2019-07-10

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-07-10
Critical
0
Units
38,280

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • LowFDA (Drugs)··2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone tablets due to out-of-specification assay results.

    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
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone Tablets because they failed potency testing.

    Product
    Esterified 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 13925-172-01
    Category
    Distribution
    0 states