February 2014 FDA Recall Drug by Aaron Industries Inc
D-1097-2014 - Presence of Precipitate

This Class III drug recall was voluntarily initiated by Aaron Industries Inc on February 4, 2014 for the product Drug. The FDA reported the reason for recall as presence of precipitate. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1097-2014

Reason for Recall
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Initiated
02-04-2014
Reported
03-12-2014
Quantity
43,921 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67434
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-29-2014
Product Description About Product Description
Full technical description of the product.
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.

Batch or Lot Expiration Information

Lot# : 151631, Exp 10/15 and 152767, Exp 11/15