Cefuroxime Sterile Ophthalmic Injection Recalled Due to Sterility Concerns
Edge Pharma is recalling Cefuroxime sterile ophthalmic solution for injection because the company cannot assure the product meets sterility requirements. The recall affects approximately 1,720 syringes distributed nationwide.
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 FDA classified this as a Class II recall. The hazard—lack of sterility assurance in an intraocular injection product—creates a direct risk of serious infection in a high-risk medical procedure, warranting a Severe classification per the rubric for FDA Class II recalls with serious potential consequences.
Plain-English summary
Edge Pharma, LLC is recalling Cefuroxime, Sterile Ophthalmic Solution for Injection (3mg/0.3mL, 10 mg/mL), 0.3 mL single-use syringes for intraocular injection due to a lack of assurance of sterility. The affected product has NDC number 05446-1003-01 and was distributed nationwide. Approximately 1,720 syringes are included in this recall.
The specific lot codes affected are: 08-2021-30@1 with expiration date 12/20/2021; 09-2021-21@5 with expiration date 01/03/2022; and 10-2021-18@5 with expiration date 02/07/2022.
Cefuroxime is an antibiotic injection used in eye surgery. If this product does not meet sterility assurance requirements, it poses a potential risk of infection to patients receiving intraocular injection. Patients and healthcare providers who have received or administered this product should contact Edge Pharma or consult their healthcare provider for guidance.
The recalled product
- Product
- Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Injectable
- Hazard
- sterility-assurance-failure
- infection-risk
- intraocular-injection
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)
- 08-2021-30@1 12/20/2021
- 09-2021-21@5 01/03/2022 & 10-2021-18@5 02/07/2022
Distribution
Distributed nationwide across the United States.
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