Ceftazidime Intravitreal Solution Recalled for Sterility Assurance Failure
Vital Care Compounder is recalling Ceftazidime intravitreal injection solutions due to manufacturing conditions that cannot guarantee product sterility. Affected lots were distributed to patients in Alabama, Louisiana, Mississippi, and Tennessee.
What this means for you
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 recall involving sterile injectable ophthalmic product with manufacturing process unable to guarantee sterility. No illnesses or injuries reported; hazard is theoretical under rubric constraint. Intravitreal injections are risk-of-harm products where injury has not been reported, qualifying for score 3.
Plain-English summary
Vital Care Compounder is recalling specific lots of Ceftazidime intravitreal 2.25 mg/0.1 mL injection solution. The recall affects three lots (65434, 66349, and 66868) with beyond-use dates of October 13, November 5, and November 18, 2022, respectively.
The products are being recalled because FDA inspection determined they were produced in a manner that cannot guarantee the sterility of products represented as sterile.
The affected products were distributed in Alabama, Louisiana, Mississippi, and Tennessee. Patients who received these recalled injections should consult their healthcare provider regarding potential need for follow-up evaluation or alternative treatment options.
The recalled product
- Product
- CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic / Injectable
- Hazard
- lack-of-sterility-assurance
- infection-risk
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 (6)
- Lots: 65434
- BUD: 10/13/2022
- 66349
- BUD: 11/05/2022
- 66868
- BUD: 11/18/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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