The Recall Desk

FDA (Drugs) recall action 86593

Denton Pharma, 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
—

Why these products were recalled

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

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

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2020-11-11

    Denton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2020-11-11

    Denton Pharma Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Denton Pharma, Inc. is recalling specific 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, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, N
    Category
    Distribution
    1 state