Drug recall D-0422-2023
Product
Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 7.
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: a )R2200589, R2200689, R2200690, R2201232, Exp. Date 4/30/2024
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 32,688 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.