Prestige Brands Holdings: 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,N

Is my product affected?

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

• UPC 814832013544

Check against the official notice below — it lists the full affected range.

What happened

PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, a 4 fluid ounce liquid medication containing diphenhydramine HCl and phenylephrine HCl, has been recalled due to the presence of precipitate—small amounts of the active ingredient diphenhydramine that separated from the liquid solution. The affected product was distributed nationwide and to one location in Libya, affecting approximately 12,269 cases containing 36 bottles each. The recalled medication carries UPC 814832013544 and includes 17 different lot codes with expiration dates ranging from May 2014 through September 2015.

The source document does not specify a remedy or any instructions for what consumers should do with recalled product in their possession.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Distribution: Nationwide, and one consignee in Libya Quantity: 12,269 cases/36 bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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• Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-102014-05-02
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All FDA (Drug enforcement) recalls