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D-1353-2014 Class III Terminated

Recalled by Prestige Brands Holdings — Tarrytown, NY

FDA drug recall D-1353-2014 was initiated by Prestige Brands Holdings on Apr 25, 2014 and is designated Class III. Reason for recall: Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution The recall status is terminated (terminated Sep 15, 2015). Affected quantity: 17,479 cases/12 dual packs.

Recall Details

Product Type: Drugs
Report Date: Jun 4, 2014
Initiation Date: Apr 25, 2014
Termination Date: Sep 15, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,479 cases/12 dual packs

Product Description

PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523

Reason for Recall

Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

Distribution Pattern

Nationwide, and one consignee in Libya

Code Information

UPC 814832013523 Lots: Expiry Date 148342 07/2015 148347 08/2015 149297 08/2015 149382 07/2015 149516 08/2015 152298 08/2015 73143 04/2014 73719 05/2014 74195 06/2014 74805 06/2014 75180 06/2014 79186 09/2014 79323 09/2014

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1353-2014
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.