Drug product
NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9).
D-758-2014
Product summary
- Event
- Event 65490
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-758-2014
Official wording
Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Code information: Lot #: a) 10112236, Exp 4/30/2014 and 10122295, Exp 9/30/2014; b) 10093319, Exp 6/30/2013 and 10100417, Exp 9/30/2013.
Distribution pattern: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance