September 2012 FDA Recall Drug by Genentech, Inc.
D-097-2013 - Short Fill

This Class III drug recall was voluntarily initiated by Genentech, Inc. on September 27, 2012 for the product Drug. The FDA reported the reason for recall as short fill. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-097-2013

Reason for Recall
Short Fill: some bottles contained less than 120-count per labeled claim.
Initiated
09-27-2012
Reported
12-26-2012
Quantity
1128 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63874
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Genentech, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-20-2014
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

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