Status
Terminated
Drug Enforcement D-310-2013
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Classification
Class III
Report Date
May 8, 2013
Termination Date
August 14, 2014
Product Information
- Product description
- Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
- Product quantity
- 27,718 cases 16 count and 7,551 cases 576 count
- Reason for recall
- Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Reckitt Benckiser Inc
- Address
-
399 Interpace Parkway
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-310-2013
- Event ID
- 64652
- Recall initiation date
- March 18, 2013
- Center classification date
- May 1, 2013
- Code info
- 16 count: AG156 Exp 11/13, AG257 Exp 12/13, AH388 02/14, AJ167 03/14, AL367 Exp 05/14, AL555 & AL568 Exp 06/14, AM141 Exp 07/14. 576 Count: AK505 Exp 04/14, AK570 Exp 05/14, AH368 & AH398 Exp 02/14, AJ000 Exp 03/14, AG596 Exp 12/13,
- More code info
- —