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Recall Observatory FDA recall evidence

Drug 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.

D-1097-2014

February 04, 2014

Class III

Product summary

Firm
Aaron Industries Inc
Event
Event 67434
Status
Terminated
Classification
Class III
Quantity
43,921 bottles
Official record key
drug-enforcement:D-1097-2014

Official wording

Reason: 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.

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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.