Recalls / Class II
Class IID-0425-2023
Product
rOPINIRole Tablets USP 0.25 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 16729-232-01, UPC 3 16729 23201 2;
- Brand name
- Ropinirole
- Generic name
- Ropinirole
- Active ingredient
- Ropinirole Hydrochloride
- Route
- Oral
- NDCs
- 16729-232, 16729-233, 16729-234, 16729-235, 16729-236, 16729-237, 16729-238
- FDA application
- ANDA204022
- Affected lot / code info
- Batches: P2102086, Exp. Date 3/31/2023; P2105094, P2105095, P2105097, P2105096, P2105093, Exp. Date 7/31/2023; P2106490, P2106491, P2106493, P2106492, P2106494, Exp. Date 9/30/2023; P2201069, P2201068, P2201067, Exp. Date 1/31/2024; P2203516, Exp. Date 5/31/2024
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 139,332 bottles
- Distribution pattern
- United States including Puerto Rico and Canada
Timeline
- Recall initiated
- 2023-02-07
- FDA classified
- 2023-03-02
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0425-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.