FDA recall record

Aaron Industries Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold recall — FDA D-188-2013

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

Class IIIclassification
D-188-2013official record ID
Mar 13, 2013report date

Recall record at a glance

Official recordD-188-2013
CategoryDrug Recalls
ClassificationClass III
FDA record statusTerminated
Recalling firmAaron Industries Inc.
Report dateMar 13, 2013
Recall initiation dateJan 18, 2013
Quantity43,464 bottles (3,622 cases)
LocationLynwood, CA, United States

Official product description

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.

Why the product was recalled

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.

Distribution information

Nationwide

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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