Recalls / Class II
Class IID-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
- 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: P2105099, P2105098, Exp. Date 7/31/2023, P2106507, P2106508, P2106510, P2106509, Exp. Date 9/30/2023, P2202750, Exp. Date 4/30/2024
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
- 14,928 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-0429-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.