D-758-2014 Class II Terminated
FDA drug recall D-758-2014 was initiated by Novartis Consumer Health on June 18, 2013 and is designated Class II. Reason for recall: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. The recall status is terminated (terminated November 4, 2014).
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2014
- Initiation Date
- June 18, 2013
- Termination Date
- November 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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).
Reason for Recall
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Distribution Pattern
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
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.