Recalls / Class II

Class IID-757-2014

Product

NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5).

Affected lot / code info

Lot #: a) 10094895, Exp 7/31/2013; 10098586, Exp 9/30/2013; 10104820, Exp 12/31/2013; 10109982, Exp 2/28/2014; 10110876, Exp 3/31/2014; 10114393, Exp 5/31/2014; 10119851, Exp 7/31/2014; 10122313, Exp 9/30/2014; b) 10097661, Exp 8/31/2013; 10099912, Exp 9/30/2013; 10105539, Exp 12/31/2013; 10109980, Exp 2/28/2014; 10114396, Exp 5/31/2014; 10119849, Exp 7/31/2014; 10122312, 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

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-757-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.