Status
Terminated
Drug Enforcement D-186-2013
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
March 13, 2013
Termination Date
November 1, 2013
Product Information
- Product description
- Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
- Product quantity
- 35,652 bottles (2,971 cases)
- 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
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Aaron Industries Inc
- Address
-
11865 Alameda St, 11840 S Alameda ST
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-186-2013
- Event ID
- 64298
- Recall initiation date
- January 18, 2013
- Center classification date
- March 7, 2013
- Code info
- Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307
- More code info
- —