PediaCare Nighttime Cold Syrup Recalled for Diphenhydramine Precipitate
Prestige Brands Holdings is recalling PediaCare Nighttime Multi-Symptom Cold syrup due to the presence of diphenhydramine precipitate in the solution.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The issue is a physical change in the solution (precipitate) rather than a toxic contamination or mislabeling of a dangerous allergen.
Plain-English summary
Prestige Brands Holdings is recalling PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold syrup, 4 FL OZ (118 mL), distributed by Medtech Products, Inc. The recall involves 12,269 cases containing 36 bottles each. The product is identified by UPC 814832013544 and includes specific lot numbers with expiry dates ranging from May 2014 to February 2015.
The recall was initiated because small amounts of diphenhydramine precipitated out of solution. The product was distributed nationwide and to one consignee in Libya.
Consumers should check their inventory for the specific UPC and lot numbers listed in the recall notice. If the product is found, consumers should stop using it and contact the recalling firm or a healthcare provider for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Prestige Brands Holdings
- Category
- Drug — OTC Cold Medicine
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Prestige Brands Holdings under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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