Ceftazidime Sterile Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma is recalling Ceftazidime sterile ophthalmic solution for intraocular injection due to lack of assurance of sterility. The recall affects 168 syringes distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug product with a contamination risk (lack of sterility assurance). Although no illnesses or injuries have been reported, the hazard involves a high-risk sterile product for intraocular injection, meeting the rubric criterion for a high-risk product where injury has not yet been reported.
Plain-English summary
Edge Pharma, LLC is recalling Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL) in 0.5 mL single-use syringes for intraocular injection. The recalled product was manufactured under NDC 05446-0733-01 with lot codes 09-2021-01@6 (dated 12/14/2021) and 10-2021-27@4 (dated 01/01/2022).
The recall is due to lack of assurance of sterility of the product. A total of 168 syringes were distributed nationwide.
Patients who have received this product should contact their healthcare provider. Healthcare providers should review patient records to identify those who may have received the recalled product and take appropriate clinical action.
The recalled product
- Product
- Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
- Manufacturer
- Edge Pharma, LLC
- Affected units
- 168
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 (1)
- 09-2021-01@6 12/14/2021 & 10-2021-27@4 01/01/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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