The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-185-2013·Announced 2013-03-13

Aaron Industries Recalls Walgreens Wal-Tussin CF Max Due to Precipitate

Aaron Industries is recalling 6,108 bottles of Walgreens Wal-Tussin CF Max because a white substance, confirmed as the active ingredient guaifenesin, was observed in some bottles.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Aaron Industries Inc is recalling 6,108 bottles (509 cases) of Well at Walgreens Wal-Tussin CF Max, Maximum Strength Adult Non-Drowsy, Multi-Symptom Cold. The product is distributed by Walgreen Co and contains dextromethorphan HBr, guaifenesin, and phenylephrine HCI.

The recall was initiated due to the presence of a white precipitate in some bottles. The white substance has been confirmed to be guaifenesin, an active ingredient in the medication. The source notes that if the product is shaken or warmed, the white particles go into the solution.

The affected product is identified by Lot# 80798 and FP-49-081-14870. The recall is classified as Class III by the FDA, indicating that there is a remote probability that adverse health consequences would be likely to be temporary or medically reversible under normal use.

The recalled product

Product
Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
Manufacturer
Aaron Industries Inc
Category
Drug — Cold and Flu
Hazard

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 (2)

  • Lot# 80798
  • FP-49-081-14870

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Aaron Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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