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Recall Observatory FDA recall evidence

Drug product

Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)

D-763-2014

June 18, 2013

Class II

Product summary

Firm
Novartis Consumer Health
Event
Event 65490
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-763-2014

Official wording

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

Code information: Lot #: Russia product: 10117513,10117515, 10117517, 10117520, 10118676, 10118680, Exp 6/30/2013 and Former Soviet Union product: 10116986, 10116988, Exp 8/31/2013.

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