Genentech Recalls Cotellic Tablets Due to Oversized Tablet Discovery
Genentech is recalling 748 bottles of Cotellic (cobimetinib) tablets because an oversized tablet was found in a bottle. The affected product was distributed in New Jersey and Illinois.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as dosing errors from an oversized tablet) are rated as Severe (4), as they are not Class I but involve a significant risk of harm.
Plain-English summary
Genentech Inc. is voluntarily recalling 748 bottles of Cotellic (cobimetinib) Tablets, 20 mg, 63 count. The recall was initiated after an oversized tablet was discovered in a bottle. The product is a prescription-only medication made in Switzerland and distributed by Genentech USA, Inc., in South Francisco, California.
The affected product includes bottles with lot codes B1009MC, B1009M9, B1009MA (expiration 02/18) and B1009MT (expiration 02/19). The NDC for the product is 50242-717-01. The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected bottles were distributed in New Jersey and Illinois. Patients and healthcare providers should check their inventory for the specific lot codes and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for credit. Consumers should not take the recalled product and should contact their healthcare provider for further instructions.
The recalled product
- Product
- COTELLIC (COBIMETINIB)
- Brand
- COTELLIC
- Manufacturer
- Genentech Inc.
- Category
- Drug — Oncology
- Affected units
- 748
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- B1009MC
- B1009M9
- B1009MA
- Exp. 02/18 B1009MT 02/19
Distribution
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