P & L Development, LLC recalls Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels:…

Recall date

April 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0694-2017

FDA classification

Class III

Brand / firm

P & L Development, LLC

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.