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Recall Observatory FDA recall evidence

Drug 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, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523

D-1353-2014

April 25, 2014

Class III

Product summary

Firm
Prestige Brands Holdings
Event
Event 68130
Status
Terminated
Classification
Class III
Quantity
17,479 cases/12 dual packs
Official record key
drug-enforcement:D-1353-2014

Official wording

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

Code information: UPC 814832013523 Lots: Expiry Date 148342 07/2015 148347 08/2015 149297 08/2015 149382 07/2015 149516 08/2015 152298 08/2015 73143 04/2014 73719 05/2014 74195 06/2014 74805 06/2014 75180 06/2014 79186 09/2014 79323 09/2014

Distribution pattern: Nationwide, and one consignee in Libya

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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