# FDA recall D-1353-2014

> **Prestige Brands Holdings** · Class III · drug recall initiated 2014-04-25.

## 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

## Reason for recall

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

## Distribution

Nationwide, and one consignee in Libya

## Key facts

- **Recall number:** D-1353-2014
- **Recalling firm:** Prestige Brands Holdings
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-25
- **Report date:** 2014-06-04
- **Termination date:** 2015-09-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1353-2014

## Citation

> AI Analytics. FDA recall D-1353-2014. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-1353-2014. Source: US FDA. Licensed CC0.

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