D-097-2013 Class III Terminated
FDA drug recall D-097-2013 was initiated by Genentech, Inc. on Sep 27, 2012 and is designated Class III. Reason for recall: Short Fill: some bottles contained less than 120-count per labeled claim. The recall status is terminated (terminated Nov 20, 2014). Affected quantity: 1128 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 26, 2012
- Initiation Date
- Sep 27, 2012
- Termination Date
- Nov 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1128 bottles
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.
Reason for Recall
Short Fill: some bottles contained less than 120-count per labeled claim.
Distribution Pattern
Nationwide
Code Information
Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-097-2013
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026