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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68130

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 25, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Prestige Brands Holdings

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-1352-2014
Recall number
D-1352-2014
Initiated
April 25, 2014
Classification
Class III
Status
Terminated
Recalling firm
Prestige Brands Holdings
Quantity
12,269 cases/36 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide, and one consignee in Libya

drug · product 2 of 2

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
Recall number
D-1353-2014
Initiated
April 25, 2014
Classification
Class III
Status
Terminated
Recalling firm
Prestige Brands Holdings
Quantity
17,479 cases/12 dual packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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