FDAFDA · Food and drugs·Recall number D-0426-2023
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
Published March 8, 2023 · Recall initiated: February 7, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: recalling drug products following an FDA inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ROPINIROLE
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- United States including Puerto Rico and Canada
- UPC
- 316729233019
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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