FDA recall D-753-2014

Novartis Consumer Health · Class II · drug

Product

Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1.

Reason for recall

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Distribution

Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.

Key facts

Status: Terminated
Initiation date: 2013-06-18
Report date: 2014-01-29
Termination date: 2014-11-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-753-2014