FDA recall D-620-2013

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2013-05-03

Report date

2013-07-03

Termination date

2013-10-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Compton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-620-2013