The Recall Desk

FDA (Drugs) recall action 85797

Teva Pharmaceuticals USA recalled 2 products on 2020-07-01

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
2020-07-01
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2020-07-01

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

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected the impurity NDMA above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2020-07-01

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

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
    Category
    Distribution
    1 state