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.
FDA recall notice · announced December 26, 2012 · Genentech
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Notes
Distribution: Nationwide
Lot/code information: Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15
Quantity: 1128 bottles
Status: Terminated
Products in this recall event:
- 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 (D-097-2013)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.