PlainRecalls
FDA Drug Moderate Class II Terminated

Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.

Reported: January 29, 2014 Initiated: June 18, 2013 #D-754-2014

Product Description

Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.

Reason for Recall

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

Details

Recalling Firm
Novartis Consumer Health
Units Affected
292,320 cartons
Distribution
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Location
Lincoln, NE

Frequently Asked Questions

What product was recalled?
Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.. Recalled by Novartis Consumer Health. Units affected: 292,320 cartons.
Why was this product recalled?
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-754-2014.