The Recall Desk

FDA (Drugs) recall action 82827

Zydus Pharmaceuticals USA Inc recalled 14 products on 2019-06-26

The FDA (Drugs) publishes a recall like this one as 14 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 14 pages.

Products
14
Announced
2019-06-26
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

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

1–14 of 14

  • ModerateFDA (Drugs)··2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.5 mg due to cross-contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-26

    Zydus Recalls Anastrozole Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Anastrozole tablets due to cross-contamination from cleaning failures. The recall covers 1.4 million bottles distributed nationwide.

    Product
    ANASTROZOLE (ANASTROZOLE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross Contamination

    Zydus Pharmaceuticals USA Inc is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Methylprednisolone tablets due to cross-contamination caused by cleaning failures. The affected lots are distributed nationwide.

    Product
    METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 1 mg due to cross-contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination Risk

    Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 1.5 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
    Category
    Distribution
    0 states