FDA-Drug2014-06-04Class III

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

Prestige Brands Holdings
Hazard

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

Sold states
Nationwide, and one consignee in Libya
Affected count
12,269 cases/36 bottles
Manufactured in
660 White Plains Rd, Tarrytown, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1352-2014

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