The Recall Desk

FDA (Drugs) recall action 84610

Appco Pharma LLC 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
2,256

Why these products were recalled

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

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)··2020-01-15

    Appco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Appco Pharma LLC is recalling Ranitidine Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-01-15

    Appco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Appco Pharma LLC is recalling specific lots of Ranitidine Capsules 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
    Category
    Distribution
    0 states