Drug product

Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2

D-620-2013

May 03, 2013

Class II

Product summary

Firm: Kareway Product Inc
Event: Event 53558
Status: Terminated
Classification: Class II
Quantity: 24,048 cartons
Official record key: drug-enforcement:D-620-2013

Official wording

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

Code information: Lot# 6781202 & 6781302

Distribution pattern: Nationwide in the US: CA, OR, WA. Africa.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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