Drug Enforcement D-620-2013

Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine

Status

Terminated

Classification

Class II

Report Date

July 3, 2013

Termination Date

October 28, 2013

Product Information

Product description
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
Product quantity
24,048 cartons
Reason for recall
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US: CA, OR, WA. Africa.

Location & Firm

Recalling firm
Kareway Product Inc
Address
2550 S Dominguez Hills Dr

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

Codes & Dates

Recall number
D-620-2013
Event ID
53558
Recall initiation date
May 3, 2013
Center classification date
June 26, 2013
Code info
Lot# 6781202 & 6781302
More code info
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