Drug product
Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.
D-755-2014
Product summary
- Event
- Event 65490
- Status
- Terminated
- Classification
- Class II
- Quantity
- 398,208 cartons
- Official record key
drug-enforcement:D-755-2014
Official wording
Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Code information: Lot #: 10115134, Exp 5/31/2013; 10119862, Exp 7/31/2013; 10122276, 10124325, Exp 10/31/2013.
Distribution pattern: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance