Why it was recalled
Superpotent Drug: An oversized tablet was found in a bottle.
Product description
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.
Lot numbers, UPCs & expiration codes
B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
Where it was sold
NJ and IL
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-0648-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 13, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 748 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech Inc.
Original FDA data
Every field from FDA enforcement report D-0648-2017, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 76726
- Address
- 1 Dna Way
- Code information
- B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
- Postal code
- 94080-4990
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0648-2017
- Classification
- Class II
- Recalling firm
- Genentech Inc.
- Product quantity
- 748 bottles
- Termination date
- May 12, 2017
- Reason for recall
- Superpotent Drug: An oversized tablet was found in a bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- NJ and IL
- Recall initiation date
- Mar 13, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2017