FDA recall D-310-2013

Product

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

Nationwide

Key facts

Status

Terminated

Initiation date

2013-03-18

Report date

2013-05-08

Termination date

2014-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-310-2013