Why it was recalled
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Product description
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
Lot numbers, UPCs & expiration codes
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
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-1352-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 25, 2014
- FDA report date
- Jun 4, 2014
- Quantity
- 12,269 cases/36 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prestige Brands Holdings
Original FDA data
Every field from FDA enforcement report D-1352-2014, 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 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
- Postal code
- 10591-5139
- Report date
- Jun 4, 2014
- Product type
- Drugs
- Recall number
- D-1352-2014
- Classification
- Class III
- Recalling firm
- Prestige Brands Holdings
- Product quantity
- 12,269 cases/36 bottles
- 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 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
- Distribution pattern
- Nationwide, and one consignee in Libya
- Recall initiation date
- Apr 25, 2014
- Initial firm notification
- Letter
- Center classification date
- May 28, 2014