The Recall Desk

FDA (Drugs) recall action 85811

AVKARE Inc. recalled 2 products on 2020-06-24

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
2020-06-24
Critical
0
Units
1,675,458

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.

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)··2020-06-24

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

    AvKARE Inc. is recalling 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 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulas
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2020-06-24

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

    AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Distribution
    0 states