Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Cotellic (cobimetinib)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Superpotent Drug: An oversized tablet was found in a bottle.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDC
50242-0717-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cotellic Cobimetinib NDC 50242-0717 |
FUMARATE 20 mg/1 | Tablet, Film Coated Oral |
Genentech, Inc. | Rx |
- Recalling firm
- Genentech Inc.
- NDC code
- 50242-717-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0648-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Genentech Inc.
All 2017 recalls
Class III · Low risk
Susvimo (ranibizumab injection)
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.
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class III · Low risk
Evrysdi (risdiplam)
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Other wrong potency / content recalls from 2017
All wrong potency / content recalls
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity Specifications
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class II · Moderate risk
Viokace (pancrelipase)
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
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