Status
Terminated
Drug Enforcement D-0423-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Report Date
March 8, 2023
Termination Date
April 22, 2024
Product Information
- Product description
- 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
- Product quantity
- 120 bottles
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0423-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- Code info
- Batches: R2201294, Exp. Date 8/31/2025
- More code info
- —