Recalls / Class III
Class IIID-419-2013
Product
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
- Affected lot / code info
- Lot # 82507 and 82720.
Why it 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.
Recalling firm
- Firm
- Aaron Industries Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11865 Alameda St, N/A, Lynwood, California 90262-4022
Distribution
- Quantity
- 27,144 bottles
- Distribution pattern
- Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
Timeline
- Recall initiated
- 2013-04-04
- FDA classified
- 2013-05-17
- Posted by FDA
- 2013-05-29
- Terminated
- 2013-11-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-419-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.