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Recall Observatory FDA recall evidence

Drug product

Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.

D-188-2013

January 18, 2013

Class III

Product summary

Firm
Aaron Industries Inc
Event
Event 64298
Status
Terminated
Classification
Class III
Quantity
43,464 bottles (3,622 cases)
Official record key
drug-enforcement:D-188-2013

Official wording

Reason: Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

Code information: Lot# 81198, 82183, 80797; FP-44-081-03884,

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.