Home / Recalls / Prestige Brands Holdings / D-1352-2014

D-1352-2014 Class III Terminated

Recalled by Prestige Brands Holdings — Tarrytown, NY

FDA drug recall D-1352-2014 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: 12,269 cases/36 bottles.

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: 12,269 cases/36 bottles

Product Description

PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544

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 814832013544 Lots: Expiry Date 133196 01/2015 144273 02/2015 154090 09/2015 73242 05/2014 73243 05/2014 73244 05/2014 73824 06/2014 74207 06/2014 74303 06/2014 74460 06/2014 78805 09/2014 79265 10/2014 79266 10/2014 79573 09/2014 80456 06/2014 80457 07/2014 83746 01/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1352-2014
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.