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FDAFDA · Food and drugs·Recall number D-1353-2014

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

Published June 4, 2014 · Recall initiated: April 25, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Prestige Brands Holdings
Distributor
Nationwide, and one consignee in Libya
Lot
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
Risk classification
Class III
Area (FDA)
drug
Country
United States

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