CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per cart...

FDA Recall #D-097-2013 — Class III — September 27, 2012

Recall #D-097-2013 Date: September 27, 2012 Classification: Class III Status: Terminated

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.

Recalling Firm

Genentech, Inc. — South San Francisco, CA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

1128 bottles

Distribution

Nationwide

Code Information

Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated