FDA recall D-1288-2015

Ranbaxy Inc. · Class II · drug

Product

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.

Reason for recall

Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-06-26
Report date: 2015-08-12
Termination date: 2016-04-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1288-2015