Drug recall D-0431-2023
Product
rOPINIRole Tablets USP 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 16729-238-01, UPC 3 16729 23801 4
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: P2104150, P2104151, Exp. Date 6/30/2023, P2202065, Exp. Date 3/31/2024
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 5,112 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.