Prescription eye drops recalled due to sterility assurance defect
Vital Care Compounder is recalling 378 droptainers of PRED ACETATE/GATIFLOXACIN eye drops distributed in AL, LA, MS, and TN due to inability to guarantee manufacturing sterility. No illnesses have been reported.
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 of a sterile ophthalmic product where manufacturing failures cannot guarantee sterility. While no illnesses or injuries have been reported, this meets the High severity criterion as a risk-of-harm product where potential for harm is significant.
Plain-English summary
Vital Care Compounder is recalling 378 droptainers (10 mL each) of PRED ACETATE/GATIFLOXACIN 1% / 0.5% suspension (prescription only) distributed in Alabama, Louisiana, Mississippi, and Tennessee. The affected lots are: Lot 65056 (BUD 11/18/2022) and Lot 66246 (BUD 11/19/2022).
An FDA inspection found that these products were manufactured in a manner that cannot guarantee their sterility. These eye drops are intended to be sterile preparations, and manufacturing defects that prevent assuring sterility create a potential public health concern.
Patients who received prescriptions filled with these eye drops during the relevant time period may have received a recalled lot. Those who believe they have an affected product can verify the lot number on their bottle.
The recalled product
- Product
- PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 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 drops
- Hazard
- contamination
- sterility-defect
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: 65056
- BUD: 11/18/2022
- 66246
- BUD: 11/19/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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