The Recall Desk

FDA (Drugs) recall action 68130

Prestige Brands Holdings recalled 2 products on 2014-06-04

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-06-04
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • LowFDA (Drugs)··2014-06-04

    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.

    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
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-06-04

    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.

    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
    Category
    Distribution
    0 states