PlainRecordsFDA · Drug recall
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF…
- Date
- May 29, 2013
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Terminated
- Filed by
- Aaron Industries Inc
- 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.
- 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.
- Distribution pattern
- Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
- Quantity
- 27,144 bottles
- Codes and lots
- Lot # 82507 and 82720.
- Recall started
- April 4, 2013
- Recall number
- D-419-2013
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-419-2013. The agency record governs; check it and the company before acting.