Recalls / Class II
Class IID-0648-2017
Product
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.
- Brand name
- Cotellic
- Generic name
- Cobimetinib
- Active ingredient
- Cobimetinib Fumarate
- Route
- Oral
- NDC
- 50242-717
- FDA application
- NDA206192
- Affected lot / code info
- B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
Why it was recalled
Superpotent Drug: An oversized tablet was found in a bottle.
Recalling firm
- Firm
- Genentech Inc.
- Manufacturer
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Dna Way, N/A, South San Francisco, California 94080-4990
Distribution
- Quantity
- 748 bottles
- Distribution pattern
- NJ and IL
Timeline
- Recall initiated
- 2017-03-13
- FDA classified
- 2017-04-05
- Posted by FDA
- 2017-04-12
- Terminated
- 2017-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0648-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.