April 2014 FDA Recall Drug by Aaron Industries Inc
D-1286-2014 - Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.

This Class III drug recall was voluntarily initiated by Aaron Industries Inc on April 11, 2014 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.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1286-2014

Reason for Recall
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Initiated
04-11-2014
Reported
05-07-2014
Quantity
108,792 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68003
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.
02-13-2015
Product Description About Product Description
Full technical description of the product.
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.

Batch or Lot Expiration Information

Lot# : 73762, 80030, 82053, 83032, 73768, 76414, 78222, 78441, 140423, 140494, 142396,145460,145959, 73831, 73832, 78440, 79819, 82606, 80969, 140530, 142413, 145461, 74163; Exp 06/14
Lot# :148820, 149396, 149995, 150208, 150422, 150599, 151023, 151071,151337, 148931,151072. ; Exp 08/15