FDA recall D-1353-2014

Prestige Brands Holdings · Class III · drug

Product

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

Nationwide, and one consignee in Libya

Key facts

Status: Terminated
Initiation date: 2014-04-25
Report date: 2014-06-04
Termination date: 2015-09-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1353-2014