Status
Terminated
Drug Enforcement D-419-2013
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.
Classification
Class III
Report Date
May 29, 2013
Termination Date
November 1, 2013
Product Information
- Product description
- 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.
- Product quantity
- 27,144 bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
Location & Firm
- Recalling firm
- Aaron Industries Inc
- Address
-
11865 Alameda St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-419-2013
- Event ID
- 52863
- Recall initiation date
- April 4, 2013
- Center classification date
- May 17, 2013
- Code info
- Lot # 82507 and 82720.
- More code info
- —