Drug Enforcement D-763-2014

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

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

November 4, 2014

Product Information

Product description
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)
Product quantity
—
Reason for recall
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.

Location & Firm

Recalling firm
Novartis Consumer Health
Address
10401 Hwy 6

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-763-2014
Event ID
65490
Recall initiation date
June 18, 2013
Center classification date
January 17, 2014
Code info
Lot #: Russia product: 10117513,10117515, 10117517, 10117520, 10118676, 10118680, Exp 6/30/2013 and Former Soviet Union product: 10116986, 10116988, Exp 8/31/2013.
More code info
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