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.
D-097-2013
Product summary
- Firm
- Genentech, Inc.
- Event
- Event 63874
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1128 bottles
- Official record key
drug-enforcement:D-097-2013
Official wording
Reason: Short Fill: some bottles contained less than 120-count per labeled claim.
Code information: Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Short Fill: some bottles contained less than 120-count per labeled claim.