Key Takeaway

NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per c by Novartis Consumer Health was recalled on June 18, 2013. The hazard: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

FDA Drug Class II Terminated

NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per c

Recalled: June 18, 2013 D-759-2014

Description

NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. Also packaged under foreign labels: Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product);

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per c

Drugs

Company Information

Novartis Consumer Health

Lincoln, NE, United States

View all 60 recalls by Novartis Consumer Health →

Distribution

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

Related Recalls

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.