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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Genentech Inc.
- Reason for Recall:
- Superpotent Drug: An oversized tablet was found in a bottle.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
Distribution:
Distributed in: NJ, IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0648-2017
Related Recalls
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.