FDA Drug recall D-1353-2014
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MU…
- FDA Drug
- Class III
- terminated
- Published 2014-06-04
On 2014-06-04 the FDA classified a Class III recall of PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MU… by Prestige Brands Holdings, citing presence of Precipitate; small amounts of diphenhydramine precipitated out of solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1353-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-04-25 |
| Published | 2014-06-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Prestige Brands Holdings |
| Distribution | US |
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
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Identifiers
| upc | 814832013523 |
|---|---|
| code_info | UPC 814832013523 Lots: Expiry Date 148342 07/2015 148347 08/2015 149297 08/2015 149382 07/2015 149516 08/2015…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 |
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-1353-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.