The Recall Desk
LowFDA (Drugs)·D-1286-2014·Announced 2014-05-07

Aaron Industries Recalls Tussin DM Cough Syrup Due to Precipitate

Aaron Industries is recalling 108,792 bottles of Tussin DM cough syrup because a white substance, identified as the active ingredient Guaifenesin, was observed in some bottles.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard involves the presence of an active ingredient (Guaifenesin) as a precipitate, which is a cosmetic or quality defect rather than a toxic contamination.

Plain-English summary

Aaron Industries Inc is recalling 108,792 bottles of Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold. The product is an over-the-counter cough suppressant and expectorant containing Dextromethorphan HBr and Guaifenesin. The recall covers various brand names and bottle sizes, including CareOne, Our Family, Premier Value, Rexall, Safeway, and Select Brand, distributed nationwide.

The recall was initiated due to the presence of a precipitate, described as a white substance, in some bottles. The substance has been confirmed to be Guaifenesin, which is an active ingredient in the product. The affected lots include specific lot numbers with expiration dates of 06/14 and 08/15.

Consumers who have purchased these products should check their bottles for the presence of a white substance. If the product is affected, consumers should stop using it and return it to the place of purchase for a refund or contact the distributor for further instructions.

The recalled product

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, La
Affected units
108,792

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: 73762
  • 80030
  • 82053
  • 83032
  • 73768
  • 76414
  • 78222
  • 78441
  • 140423
  • 140494
  • 142396
  • 145460
  • 145959
  • 73831
  • 73832
  • 78440
  • 79819
  • 82606
  • 80969
  • 140530

Distribution

Distributed nationwide across the United States.