Eli Lilly Recalls ERBITUX Vials Due to Missing Primary Container Labels
Eli Lilly is recalling 9,380 vials of ERBITUX (cetuximab) because some may be missing primary container labels. The recall covers specific states and Puerto Rico.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is a packaging/labeling defect (missing label) rather than a contamination or functional defect.
Plain-English summary
Eli Lilly & Co is recalling 9,380 vials of ERBITUX (cetuximab) Injection, 200 mg/100 mL (2 mg/mL). The recall is due to a labeling issue where the primary container label on the vial may be missing.
The affected product is Lot number C1700167, with an expiration date of 9/2020. The product was distributed to Alabama, Arizona, California, Kansas, Louisiana, Mississippi, Ohio, Oregon, Tennessee, Texas, and Puerto Rico.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the primary container label is missing, the product should not be used. Contact Eli Lilly & Co for further instructions or to arrange for the return of the affected product.
The recalled product
- Product
- ERBITUX (CETUXIMAB)
- Brand
- ERBITUX
- Manufacturer
- Eli Lilly & Co
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 9,380
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 (2)
- Lot number: C1700167
- exp 9/2020
Distribution
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