Status
Terminated
Drug Enforcement D-097-2013
Short Fill: some bottles contained less than 120-count per labeled claim.
Classification
Class III
Report Date
December 26, 2012
Termination Date
November 20, 2014
Product Information
- Product description
- 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.
- Product quantity
- 1128 bottles
- Reason for recall
- Short Fill: some bottles contained less than 120-count per labeled claim.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Genentech, Inc.
- Address
-
1 DNA Way
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-097-2013
- Event ID
- 63874
- Recall initiation date
- September 27, 2012
- Center classification date
- December 20, 2012
- Code info
- Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15
- More code info
- —