Drug recall D-0423-2023
Product
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: R2201294, Exp. Date 8/31/2025
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 120 bottles
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Pravastatin Sodium – drug information
- NDC 16729-008 Pravastatin Sodium · Pravastatin Sodium 10 mg/1 · Accord Healthcare Inc.
- NDC 16729-011 Pravastatin Sodium · Pravastatin Sodium 80 mg/1 · Accord Healthcare Inc.
- NDC 16729-010 Pravastatin Sodium · Pravastatin Sodium 40 mg/1 · Accord Healthcare Inc.
- NDC 16729-009 Pravastatin Sodium · Pravastatin Sodium 20 mg/1 · Accord Healthcare Inc.