The Recall Desk
LowFDA (Drugs)·D-187-2013·Announced 2013-03-13

Aaron Industries Recalls Select Brand Cough Control CF Max Due to Precipitate

Aaron Industries Inc is recalling Select Brand Cough Control CF Max bottles due to the presence of a white precipitate, identified as the active ingredient guaifenesin.

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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the precipitate is an active ingredient that dissolves upon shaking or warming.

Plain-English summary

Aaron Industries Inc is recalling 5,676 bottles (473 cases) of Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF. The product is a 4 fl.oz 12-pack containing dextromethorphan HBr 10 mg, guaifenesin 200 mg, and phenylephrine HCI 5 mg. The recall affects Lot# 71648 and 68088, with FP-47-041-02535. The product was distributed nationwide.

The recall was initiated because a white substance, confirmed to be guaifenesin (an active ingredient), was observed in some bottles. The source notes that if the product is shaken or warmed, the white particles go into the solution. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have purchased this product should check their lot numbers against the recalled lots listed above. If the product matches the recalled lot numbers, consumers should stop using it and contact Aaron Industries Inc or their point of purchase for further instructions.

The recalled product

Product
Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.
Manufacturer
Aaron Industries Inc
Category
Drug — Cough and Cold Medicine
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 (3)

  • Lot# 71648
  • 68088
  • FP-47-041-02535

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 →

Related recalls

Same manufacturer · Aaron Industries Inc

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Same hazard · precipitate

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