Recalls / Class III
Class IIID-1097-2014
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.
- Affected lot / code info
- Lot #: 151631, Exp 10/15 and 152767, Exp 11/15
Why it was recalled
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.
Recalling firm
- Firm
- Aaron Industries Inc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 11865 Alameda St, Lynwood, California 90262-4022
Distribution
- Quantity
- 43,921 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-02-04
- FDA classified
- 2014-02-28
- Posted by FDA
- 2014-03-12
- Terminated
- 2014-10-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1097-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.