Drug recall D-0350-2025
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 for recall
CGMP Deviations
Lots and codes
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
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- N/A
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 13, 2025
Related products
- Pravastatin Sodium – drug information
- NDC 16714-558 Pravastatin Sodium · Pravastatin Sodium 10 mg/1 · NorthStar RxLLC
- NDC 16714-570 Pravastatin Sodium · Pravastatin Sodium 80 mg/1 · NorthStar RxLLC
- NDC 16714-560 Pravastatin Sodium · Pravastatin Sodium 40 mg/1 · NorthStar RxLLC
- NDC 16714-559 Pravastatin Sodium · Pravastatin Sodium 20 mg/1 · NorthStar RxLLC