Cyclosporin 0.07% Ophthalmic Solution Recalled Due to Sterility Concerns
Pharmacy Plus recalls 67 bottles of Cyclosporin 0.07% ophthalmic solution across four states due to manufacturing process that cannot guarantee sterility.
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 with no reported illnesses or injuries. The non-sterile ophthalmic solution presents a credible risk of serious eye infection, meeting the 'High' severity threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 67 bottles of Cyclosporin 0.07% Ophthalmic Solution. This is a prescription-only sterile ophthalmic medication.
During FDA inspection, the agency determined that the manufacturing process used to produce these bottles cannot guarantee the product's sterility. Sterile ophthalmic solutions must be manufactured under conditions that ensure complete elimination of microorganisms, as contamination can cause serious eye infections.
The recalled product was distributed in Alabama, Louisiana, Mississippi, and Tennessee. The recall includes two lots: Lot 59638 (Beyond Use Date 11/25/2022) and Lot 64261 (Beyond Use Date 04/30/2023).
If you have this medication, contact your pharmacist or healthcare provider. Do not use the product. Return it to your pharmacy or healthcare provider for safe disposal.
The recalled product
- Product
- CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic
- Hazard
- 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 (4)
- Lots: 59638
- BUD: 11/25/2022
- 64261
- BUD: 04/30/2023
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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