Multi-event April 2014 FDA Recall Drug by Prestige Brands Holdings

This Multi-event Class III drug recall was voluntarily initiated by Prestige Brands Holdings on April 25, 2014 for the product Drug. The FDA reported the reason for recall as presence of precipitate; small amounts of diphenhydramine precipitated out of solution. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1352-2014 TERMINATED D-1353-2014 TERMINATED

Recall Number: D-1352-2014

Reason for Recall
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Initiated
04-25-2014
Reported
06-04-2014
Quantity
12,269 cases/36 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68130
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Prestige Brands Holdings
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, and one consignee in Libya
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-15-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-1353-2014

Reason for Recall
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Initiated
04-25-2014
Reported
06-04-2014
Quantity
17,479 cases/12 dual packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68130
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Prestige Brands Holdings
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, and one consignee in Libya
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-15-2015
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 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