The Recall Desk

FDA (Drugs) recall action 80356

Wockhardt Limited recalled 2 products on 2018-07-18

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
2018-07-18
Critical
0
Units
49,338

Why these products were recalled

Failed Impurities/Degradation Specifications

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)··2018-07-18

    Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Wockhardt Limited is recalling specific batches of Enalapril Maleate Tablets USP because they failed impurity and degradation specifications.

    Product
    Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-07-18

    Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Wockhardt Limited is recalling specific batches of Enalapril Maleate Tablets USP because they failed impurity and degradation specifications.

    Product
    Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
    Category
    Distribution
    0 states