Recalls / Class III
Class IIID-097-2013
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.
- Affected lot / code info
- Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15
Why it was recalled
Short Fill: some bottles contained less than 120-count per labeled claim.
Recalling firm
- Firm
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 DNA Way, South San Francisco, California 94080-4990
Distribution
- Quantity
- 1128 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-27
- FDA classified
- 2012-12-20
- Posted by FDA
- 2012-12-26
- Terminated
- 2014-11-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-097-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.