Recalls / Class II

Class IID-753-2014

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.

Affected lot / code info

Lot #: 10089568, Exp 5/31/2013; 10093324, 10094745, 10097626, 10097627, Exp 7/31/2013; 10098588, Exp 9/30/2013. NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief : 10093316, Exp 7/31/2013; 10098591, Exp 9/30/2013; 10101027, Exp 10/31/2013; 10102623, Exp 11/30/2013; 10106813, Exp 1/31/2014; 10115844, Exp 6/30/2014; 10124363, Exp 9/30/2014.

Why it was recalled

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

Recalling firm

Firm

Novartis Consumer Health

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

10401 Hwy 6, Lincoln, Nebraska 68517-9626

Distribution

Quantity

868,104 cartons

Distribution pattern

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

Timeline

Recall initiated

2013-06-18

FDA classified

2014-01-17

Posted by FDA

2014-01-29

Terminated

2014-11-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-753-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.