FDA recall D-097-2013

Genentech, Inc. · Class III · drug

Product

CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.

Reason for recall

Short Fill: some bottles contained less than 120-count per labeled claim.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-09-27
Report date: 2012-12-26
Termination date: 2014-11-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: South San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-097-2013