D-1352-2014 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 4, 2014
- Initiation Date
- April 25, 2014
- Termination Date
- September 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,269 cases/36 bottles
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
Reason for Recall
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Distribution Pattern
Nationwide, and one consignee in Libya
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