Class II Recall

Glenmark Pharmaceuticals Inc., USA

Product
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
Reason
CGMP Deviations
Classification
Class II
Status
Ongoing
Lot
Lot # 17221770, exp. date Aug-25 17221774, exp. date Aug-25 17231251, exp. date May-26 17231262, exp. date May-26 17232112, exp. date Sep-26 17232133, exp. date Sep-26
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Glenmark Pharmaceuticals Inc., USA — Class II Recall | MedicineWatch US