The Recall Desk

FDA (Drugs) recall action 86653

Nostrum Laboratories Inc recalled 2 products on 2020-11-11

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
2020-11-11
Critical
0
Units
33,839

Why these products were recalled

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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

  • SevereFDA (Drugs)··2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because the NDMA impurity level exceeds acceptable intake limits.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
    Category
    Distribution
    0 states