Recalls / Class II
Class IID-0398-2022
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
- Affected lot / code info
- 08-2021-30@1 12/20/2021, 09-2021-21@5 01/03/2022 & 10-2021-18@5 02/07/2022
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 1720 syringes
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2021-12-06
- FDA classified
- 2022-01-24
- Posted by FDA
- 2022-02-02
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0398-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.