PediaCare Day & Night Cold Syrup Recalled for Precipitate
Prestige Brands Holdings is recalling PediaCare Day & Night Cold syrup bottles due to the presence of precipitate.
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 is defined as a situation unlikely to cause adverse health consequences. The issue is a physical change (precipitate) rather than a toxic contamination or structural defect.
Plain-English summary
Prestige Brands Holdings is recalling PediaCare brand DAY & NIGHT Value Pack DAYTIME and NIGHTTIME MULTI-SYMPTOM Cold syrup bottles. The recall involves 17,479 cases of 12 dual packs, each containing 4 FL oz (118 mL) bottles. The product was distributed nationwide and to one consignee in Libya.
The recall was initiated because of the presence of precipitate, specifically small amounts of diphenhydramine that precipitated out of solution. The affected lots have expiry dates ranging from April 2014 to August 2015. The specific lot numbers are 148342, 148347, 149297, 149382, 149516, 152298, 73143, 73719, 74195, 74805, 75180, 79186, and 79323.
Consumers should check their inventory for the specific UPC 814832013523 and the listed lot numbers. If the product matches the description, consumers should stop using it and contact the recalling firm for instructions on disposal or return.
The recalled product
- 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…
- Manufacturer
- Prestige Brands Holdings
- Category
- Drug — Cold & Flu
- Hazard
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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