Drug product
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
D-1352-2014
Product summary
- Event
- Event 68130
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12,269 cases/36 bottles
- Official record key
drug-enforcement:D-1352-2014
Official wording
Reason: Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
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
Distribution pattern: Nationwide, and one consignee in Libya
Derived failure modes
-
Unknown
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution