Exact FDA event identifier

Event 76726

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

Event summary

Timeline bucket: March 13, 2017
Product types: Drug
Classifications: Class II
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.

D-0648-2017

Recall number: D-0648-2017
Initiated: March 13, 2017
Classification: Class II
Status: Terminated
Recalling firm: Genentech Inc.
Quantity: 748 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: An oversized tablet was found in a bottle.

Code information

B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19

Distribution pattern

NJ and IL