The Recall Desk

FDA (Drugs) recall action 82863

American Health Packaging recalled 4 products on 2019-07-03

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2019-07-03
Critical
0
Units
35,133

Why these products were recalled

GMP Deviations; possible cross contamination of product due to cleaning procedure failure.

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.

1–4 of 4

  • ModerateFDA (Drugs)··2019-07-03

    Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to cleaning procedure failures that may have caused cross-contamination.

    Product
    Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-03

    American Health Packaging Recalls Pramipexole Dihydrochloride Tablets Due to GMP Deviations

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.

    Product
    Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-03

    Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and a cleaning procedure failure that may have caused cross-contamination.

    Product
    Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-07-03

    Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.

    Product
    Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
    Category
    Distribution
    0 states