FDA recall D-752-2014

Novartis Consumer Health · Class II · drug

Product

Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.

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-752-2014