Status
Terminated
Drug Enforcement D-0409-2023
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
- Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Product quantity
- 291,378 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-0409-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- Code info
- Batches: a) P2106923, Exp. Date 9/30/2023; R2101544, Exp. Date 10/31/2023; R2200732, Exp. Date 5/31/2025; b) P2101634, Exp. Date 2/28/2023; P2102370, Exp. Date 3/31/2023; P2102321, Exp. Date 3/31/2023; P2102411, Exp. Date 3/31/2023; P2102454, Exp. Date 3/31/2023; P2103991, Exp. Date 5/31/2023; R2100954, Exp. Date 6/30/2023; R2100947, Exp. Date 6/30/2023; R2100951, Exp. Date 6/30/2023; P2106242, Exp. Date 8/31/2023; P2106928, Exp. Date 9/30/2023; P2107424, Exp. Date 9/30/2023; R2101542, Exp. Date 10/31/2023; R2101543, Exp. Date 10/31/2023; R2200026, Exp. Date 11/30/2023; R2200414, Exp. Date 2/29/2024; R2200416, Exp. Date 2/28/2025; R2200586, Exp. Date 4/30/2025; R2200679, Exp. Date 5/31/2025; R2200824, Exp. Date 5/31/2025;
- More code info
- —