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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63874

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 27, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Genentech, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-097-2013
Recall number
D-097-2013
Initiated
September 27, 2012
Classification
Class III
Status
Terminated
Recalling firm
Genentech, Inc.
Quantity
1128 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Short Fill: some bottles contained less than 120-count per labeled claim.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Short Fill: some bottles contained less than 120-count per labeled claim.

Code information

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

Distribution pattern

Nationwide