RecallRadar

FDA Drug recall D-1352-2014

PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by…

On 2014-06-04 the FDA classified a Class III recall of PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by… by Prestige Brands Holdings, citing presence of Precipitate; small amounts of diphenhydramine precipitated out of solution.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1352-2014
ClassificationClass III
Statusterminated
Initiated2014-04-25
Published2014-06-04
Last updated2026-09-13 11:51 UTC
CompanyPrestige Brands Holdings
DistributionUS

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

Reason

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

Identifiers

upc814832013544
code_info
UPC 814832013544 Lots: Expiry Date 133196 01/2015 144273 02/2015 154090 09/2015 73242 05/2014 73243 05/2014 73…UPC 814832013544 Lots: Expiry Date 133196 01/2015 144273 02/2015 154090 09/2015 73242 05/2014 73243 05/2014 73244 05/2014 73824 06/2014 74207 06/2014 74303 06/2014 74460 06/2014 78805 09/2014 79265 10/2014 79266 10/2014 79573 09/2014 80456 06/2014 80457 07/2014 83746 01/2015

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1352-2014%22

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