April 2013 FDA Recall Drug by Aaron Industries Inc
D-419-2013 - Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

This Class III drug recall was voluntarily initiated by Aaron Industries Inc on April 4, 2013 for the product Drug. The FDA reported the reason for recall as presence of precipitate; white substance confirmed as guaifenesin, an active ingredient was observed in some bottles. if the product is shaken or warmed the white particles goes into the solution.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-419-2013

Reason for Recall
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Initiated
04-04-2013
Reported
05-29-2013
Quantity
27,144 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
52863
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.
Aaron Industries Inc
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 in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2013
Product Description About Product Description
Full technical description of the product.
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.

Batch or Lot Expiration Information

Lot# 82507 and 82720.