Drug 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.
D-419-2013
Product summary
- Event
- Event 52863
- Status
- Terminated
- Classification
- Class III
- Quantity
- 27,144 bottles
- Official record key
drug-enforcement:D-419-2013
Official wording
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.
Code information: Lot # 82507 and 82720.
Distribution pattern: Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
Derived failure modes
-
Unknown
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.