D-0426-2023 Class II Terminated
FDA drug recall D-0426-2023 was initiated by Accord Healthcare, Inc. on February 7, 2023 and is designated Class II. Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection. The recall status is terminated (terminated April 22, 2024). Affected quantity: 181,848 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2023
- Initiation Date
- February 7, 2023
- Termination Date
- April 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 181,848 bottles
Product Description
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution Pattern
United States including Puerto Rico and Canada
Code Information
Batches: P2102133, P2102135, P2102136, Exp. Date 3/31/2023, P2104998, P2104997, P2104991, P2104992, P2104990, P2104993, P2105000, P2104999, P2105002, P2105001, Exp. Date 7/31/2023, P2106812, Exp. Date, 9/30/2023, P2200433, P2200434, P2200435, Exp. Date, 12/31/2023, P2202730, P2202729, Exp. Date 4/30/2024, P2203517, Exp. Date 5/31/2024