Why it was recalled
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide, and one consignee in Libya
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1353-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 25, 2014
- FDA report date
- Jun 4, 2014
- Quantity
- 17,479 cases/12 dual packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prestige Brands Holdings
Original FDA data
Every field from FDA enforcement report D-1353-2014, exactly as published.
Show all FDA fields
- City
- Tarrytown
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68130
- Address
- 660 White Plains Rd
- 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
- Postal code
- 10591-5139
- Report date
- Jun 4, 2014
- Product type
- Drugs
- Recall number
- D-1353-2014
- Classification
- Class III
- Recalling firm
- Prestige Brands Holdings
- Product quantity
- 17,479 cases/12 dual packs
- Termination date
- Sep 15, 2015
- Reason for recall
- Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide, and one consignee in Libya
- Recall initiation date
- Apr 25, 2014
- Initial firm notification
- Letter
- Center classification date
- May 28, 2014