Reported Mar 8, 2023 · Terminated
rOPINIRole Tablets USP 0.5 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 0.5 mg*100-count bottleRx Only
- Manufactured forAccord Healthcare, Inc., Durham
- NC 27703 Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9
- Lot codes and dates
- Batches
P2102133P2102135P2102136Exp. Date 3/31/2023P2104998P2104997P2104991P2104992P2104990P2104993P2105000P2104999P2105002P2105001Exp. Date 7/31/2023P2106812Exp. Date9/30/2023P2200433P2200434P2200435Exp. Date12/31/2023P2202730P2202729Exp. Date 4/30/2024P2203517Exp. Date 5/31/2024
- Batches
- Amount recalled
- 181,848 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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