Home / Recalls / Reckitt Benckiser Inc / D-310-2013

D-310-2013 Class III Terminated

Recalled by Reckitt Benckiser Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
May 8, 2013
Initiation Date
March 18, 2013
Termination Date
August 14, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27,718 cases 16 count and 7,551 cases 576 count

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

Reason for Recall

Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.

Distribution Pattern

Nationwide

Code Information

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,

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