The Recall Desk

FDA (Drugs) recall action 80463

MAJOR PHARMACEUTICALS recalled 2 products on 2018-08-01

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
2018-08-01
Critical
0
Units
9,330

Why these products were recalled

Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.

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.

States named across these recalls

1–2 of 2

  • LowFDA (Drugs)··2018-08-01

    Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

    Major Pharmaceuticals is recalling 5,933 cartons of Enalapril Maleate Tablets, 5 mg, due to out-of-specification degradation products.

    Product
    Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2018-08-01

    Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

    Major Pharmaceuticals is recalling specific lots of Enalapril Maleate Tablets, 2.5 mg, because the product failed impurity specifications for a degradation product.

    Product
    Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distribute
    Category
    Distribution
    1 state