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Recall Observatory FDA recall evidence

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

June 18, 2013

Class II

Product summary

Firm
Novartis Consumer Health
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

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance