D-0350-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2025
- Initiation Date
- March 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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 for Recall
CGMP Deviations
Distribution Pattern
U.S. Nationwide
Code Information
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