The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-097-2013·Announced 2012-12-26

Genentech Recalls CellCept Capsules Due to Short Fill Issues

Genentech is recalling 1,128 bottles of CellCept (mycophenolate mofetil) 250 mg capsules because some bottles contained fewer than 120 capsules as labeled.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates the product is not likely to cause adverse health consequences. The issue is a packaging/quantity discrepancy (short fill) rather than a contamination or safety defect.

Plain-English summary

Genentech, Inc. is recalling 1,128 bottles of CellCept (mycophenolate mofetil) capsules, 250 mg. The affected product is packaged in 12 x 120-count bottles per carton (NDC 0004-0259-05) and 120-count bottles (NDC 0004-0259-51). The specific lots involved are M1365B01 and M1365, both with an expiration date of 04/15. The product was manufactured in Ireland and distributed nationwide by Genentech USA, Inc.

The recall was initiated due to a "Short Fill" issue, meaning that some bottles contained fewer than 120 capsules than the labeled claim. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.

Consumers who have this product should contact Genentech for further instructions or a replacement. The recall is limited to the specific lot numbers and NDC codes listed above.

The recalled product

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.
Manufacturer
Genentech, Inc.
Category
Drug — Immunosuppressant
Hazard
Affected units
1,128

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

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