Drug recall D-0429-2023
Product
rOPINIRole Tablets USP 3 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 16729-236-01, UPC 3 16729 23601 0
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: P2105099, P2105098, Exp. Date 7/31/2023, P2106507, P2106508, P2106510, P2106509, Exp. Date 9/30/2023, P2202750, Exp. Date 4/30/2024
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 14,928 bottles
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Ropinirole – drug information
- NDC 16729-236 Ropinirole · Ropinirole Hydrochloride 3 mg/1 · Accord Healthcare Inc.
- NDC 16729-233 Ropinirole · Ropinirole Hydrochloride .5 mg/1 · Accord Healthcare Inc.
- NDC 16729-235 Ropinirole · Ropinirole Hydrochloride 2 mg/1 · Accord Healthcare Inc.
- NDC 16729-234 Ropinirole · Ropinirole Hydrochloride 1 mg/1 · Accord Healthcare Inc.
- NDC 16729-237 Ropinirole · Ropinirole Hydrochloride 4 mg/1 · Accord Healthcare Inc.
- NDC 16729-238 Ropinirole · Ropinirole Hydrochloride 5 mg/1 · Accord Healthcare Inc.
- NDC 16729-232 Ropinirole · Ropinirole Hydrochloride .25 mg/1 · Accord Healthcare Inc.