April 2017 FDA Recall Drug by P & L Development, Llc
D-0694-2017 - Subpotent

This Class III drug recall was voluntarily initiated by P & L Development, Llc on April 17, 2017 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0694-2017

Reason for Recall
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Initiated
04-17-2017
Reported
05-10-2017
Quantity
369,012 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77007
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
P & L Development, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-18-2019
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : a) A01542, A03660, A04300, A04930, Exp 03/19; A05484, A07951, A12448, Exp 07/19; Y93105, Exp 02/19; b) A04938, Exp 03/19; A08149, A12621, Exp 07/19; c) A06557, A13030, Exp 03/19; d) A00239, Exp 03/19; A05180, A09906, Exp 07/19; Y83246, Y87531, Y87680, Exp 08/18; Y91225, Y92670, Y98200, Y98674, Exp 02/19; A13354, Exp 07/19; e) A07871, A11374, Exp 03/19; A14370, A18467, Exp 07/19.