Reported May 10, 2017 · Terminated
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels:…
P & L Development, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: P & L Development, LLC · 200 Hicks St · Westbury, NY · 11590-3323
Is this the product you have?
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels
5 of 5 products
| Model / number | Product as published |
|---|---|
0-36800-39134-5 | (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24 |
3-59726-72025-0 | (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 |
0-75450-12369-2 | (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24 |
3-59726-72025-0 | (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24 |
8-83967-39839-3. | (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24 |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 A01542, A03660, A04300, A04930, Exp 03/19; A05484, A07951, A12448, Exp 07/19; Y93105, Exp 02/19 2 A04938, Exp 03/19; A08149, A12621, Exp 07/19 3 A06557, A13030, Exp 03/19 4 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 5 A07871, A11374, Exp 03/19; A14370, A18467, Exp 07/19. - Amount recalled
- 369,012 cartons
Where it was sold
- 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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