Status
Terminated
Drug Enforcement D-758-2014
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Classification
Class II
Report Date
January 29, 2014
Termination Date
November 4, 2014
Product Information
- Product description
- 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).
- Product quantity
- —
- Reason for recall
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Location & Firm
- Recalling firm
- Novartis Consumer Health
- Address
-
10401 Hwy 6
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-758-2014
- Event ID
- 65490
- Recall initiation date
- June 18, 2013
- Center classification date
- January 17, 2014
- Code info
- 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.
- More code info
- —