FDA Recalls Cefuroxime Intravitreal Injections for Sterility Defect
Pharmacy Plus Inc. recalls 460 syringes of compounded Cefuroxime intravitreal solution distributed in Alabama, Louisiana, Mississippi, and Tennessee due to manufacturing sterility defect.
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: FDA Class II manufacturing defect affecting sterility assurance of a pharmaceutical product intended for direct eye injection. No reported illnesses or injuries, with contamination hazard theoretical rather than confirmed. Per the rubric, risk-of-harm products where injury has not been reported score at most 3 (High).
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder has recalled 460 syringes of Cefuroxime intravitreal solution (1 mg/0.1 mL) distributed to patients in Alabama, Louisiana, Mississippi, and Tennessee. The affected lot numbers are 63265 (beyond-use date 01/24/2023) and 66085 (beyond-use date 04/03/2023).
FDA inspection determined that the recalled product was manufactured in a manner that cannot ensure the product's sterility. Cefuroxime intravitreal solution is administered through direct injection into the eye.
Patients who received injections with these lot numbers should contact their healthcare provider immediately. No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Intravitreal Injection
- Affected units
- 460
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 (4)
- Lots: 63265
- BUD: 01/24/2023
- 66085
- BUD: 04/03/2023
Distribution
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder 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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