Reported Mar 8, 2023 · Terminated
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
rOPINIRole Tablets USP 0.25 mg*100-count bottleRx Only
- Manufactured forAccord Healthcare, Inc., Durham
- NC 27703 Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, UPC 3 16729 23201 2
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 P2102086, Exp. Date 3/31/2023 2 P2105094, P2105095, P2105097, P2105096, P2105093, Exp. Date 7/31/2023 3 P2106490, P2106491, P2106493, P2106492, P2106494, Exp. Date 9/30/2023 4 P2201069, P2201068, P2201067, Exp. Date 1/31/2024 5 P2203516, Exp. Date 5/31/2024 - Amount recalled
- 139,332 bottles
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
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