FDA Drug Low Class III Terminated

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

Reported: June 4, 2014 Initiated: April 25, 2014 #D-1352-2014

Product Description

Reason for Recall

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

Details

Recalling Firm: Prestige Brands Holdings
Units Affected: 12,269 cases/36 bottles
Distribution: Nationwide, and one consignee in Libya
Location: Tarrytown, NY

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Prestige Brands Holdings. Units affected: 12,269 cases/36 bottles.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on June 4, 2014. Severity: Low. Recall number: D-1352-2014.