Recall record at a glance
| Official record | D-1286-2014 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Aaron Industries Inc. |
| Report date | May 7, 2014 |
| Recall initiation date | Apr 11, 2014 |
| Quantity | 108,792 bottles |
| Location | Lynwood, CA, United States |
Official product description
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.
Why the product was recalled
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
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: Telephone.
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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