Drug recall D-0442-2021
Product
Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
CFBFP
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 255 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Nuedexta – drug information
- NDC 64597-301 Nuedexta · Dextromethorphan Hydrobromide 20 mg/1; Quinidine Sulfate 10… · Avanir Pharmaceuticals, Inc.