Pharmacy Plus Eye Solution Recalled for Sterility Assurance Issues
Pharmacy Plus is recalling SERUM TEARS IN NSAL 20% Ophthalmic Solution due to lack of assurance of sterility. FDA inspection found the manufacturing process could not guarantee the product's 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: This is an FDA Class II recall. The source does not report any illnesses or injuries, only a manufacturing defect unable to guarantee product sterility. An unsterile ophthalmic solution presents a risk of eye infection, qualifying it as a high-risk product without reported injury.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling SERUM TEARS IN NSAL 20% Ophthalmic Solution, a prescription eye drop product, due to lack of assurance of sterility.
FDA inspection of the manufacturer determined that the products were manufactured in a manner that cannot guarantee sterility. Sterility is a critical requirement for pharmaceutical products intended for ophthalmic use.
The affected product lots are: 65490 (Beyond Use Date 10/14/2022), 65584 (Beyond Use Date 10/16/2022), and 66013 (Beyond Use Date 10/28/2022). Distribution was limited to Alabama, Louisiana, Mississippi, and Tennessee.
Patients who have the affected lots should contact their prescribing physician or pharmacist immediately and refrain from using the recalled product.
The recalled product
- Product
- SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic / Eye Care
- Hazard
- sterility-failure
- 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: 65490
- BUD: 10/14/2022
- 65584
- BUD: 10/16/2022
- 66013
- BUD: 10/28/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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