The Recall Desk

FDA (Drugs) recall action 84583

AAA Pharmaceutical, Inc. recalled 2 products on 2020-01-15

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
2020-01-15
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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

1–2 of 2

  • SevereFDA (Drugs)··2020-01-15

    AAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity

    AAA Pharmaceutical is recalling specific lots of Ranitidine 150 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-01-15

    AAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity

    AAA Pharmaceutical is recalling Ranitidine 150 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
    Category
    Distribution
    0 states