FDAApril 17, 2017drug

Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAG...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.

What to do

FDA enforcement status: Terminated

Brands named

p l development

UPCs

036800391345359726720250075450123692883967398393

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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