D-754-2014 Class II Terminated
FDA drug recall D-754-2014 was initiated by Novartis Consumer Health on June 18, 2013 and is designated Class II. Reason for recall: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. The recall status is terminated (terminated November 4, 2014). Affected quantity: 292,320 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2014
- Initiation Date
- June 18, 2013
- Termination Date
- November 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 292,320 cartons
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.
Distribution Pattern
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Code Information
Lot #: 10116040, Exp 6/30/2013; 10119871, Exp 7/31/2013; 10122275, Exp 9/30/2013.