Why it was recalled
Short Fill: some bottles contained less than 120-count per labeled claim.
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.
Lot numbers, UPCs & expiration codes
Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-097-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 27, 2012
- FDA report date
- Dec 26, 2012
- Quantity
- 1128 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech, Inc.
Original FDA data
Every field from FDA enforcement report D-097-2013, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63874
- Address
- 1 DNA Way
- Code information
- Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15
- Postal code
- 94080-4990
- Report date
- Dec 26, 2012
- Product type
- Drugs
- Recall number
- D-097-2013
- Classification
- Class III
- Recalling firm
- Genentech, Inc.
- Product quantity
- 1128 bottles
- Termination date
- Nov 20, 2014
- Reason for recall
- Short Fill: some bottles contained less than 120-count per labeled claim.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 27, 2012
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2012