Drug recall D-0325-2025
Product
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.
Reason for recall
CGMP Deviations
Lots and codes
Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-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 68462-198 Pravastatin Sodium · Pravastatin Sodium 80 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-197 Pravastatin Sodium · Pravastatin Sodium 40 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-195 Pravastatin Sodium · Pravastatin Sodium 10 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-196 Pravastatin Sodium · Pravastatin Sodium 20 mg/1 · Glenmark Pharmaceuticals Inc., USA