Drug recall D-0424-2023
Product
Pravastatin Sodium Tablets USP, 80 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 16729-011-15, UPC 3 16729 01115 0
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: R2201233, Exp. Date 4/30/2024
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 1970 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.