FDA recall D-754-2014

Product

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.

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-754-2014