Leiter's Recalls Cefuroxime Intravitreal Injection Due to Incorrect Formulation
Leiter's Enterprises is recalling 569 vials of Cefuroxime 10 mg/mL intravitreal injection because the drug was compounded with sterile water instead of sterile 0.9% Sodium Chloride.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, an FDA Class II recall involving a significant product defect (incorrect formulation) is categorized as Severe.
Plain-English summary
Leiter's Enterprises, Inc. is recalling 569 vials of Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial. The product is designated for ophthalmic and office use only. The recall involves Lot # 1811195 with an expiration date of 05/01/19.
The recall was initiated because the compounded sterile drug was reconstituted using sterile water instead of the required sterile 0.9% Sodium Chloride. This constitutes an incorrect product formulation.
The affected product was distributed in California, Arizona, Michigan, and New York. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35.
- Manufacturer
- Leiter's Enterprises, Inc.
- Category
- Drug — Compounded Sterile Drug
- Hazard
- Affected units
- 569
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 # 1811195
- Exp. Date: 05/01/19
Distribution
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