Acetylcysteine Eye Drops Recalled for Sterility Assurance Issues
Acetylcysteine ophthalmic solution 5% from Vital Care Compounder is recalled due to manufacturing deficiencies that cannot ensure product sterility. The affected product was distributed 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 with no reported illnesses or injuries. The hazard—lack of sterility assurance in an ophthalmic product—is theoretical per the rubric, capping the score at 3.
Plain-English summary
Vital Care Compounder has recalled ACETYLCYSTEINE OPTH 5% Solution in 15 mL droptainers because FDA inspection determined the product was manufactured in a manner that cannot guarantee sterility. The recalled product is a prescription eye drop solution.
Two lots are affected: Lot 66017 (Expiration 10/13/2022) and Lot 66177 (Expiration 10/19/2022). The product was distributed to patients in Alabama, Louisiana, Mississippi, and Tennessee.
Since this is a sterile ophthalmic product, contamination could potentially result in serious eye infections. Patients who have received this medication should consult with their healthcare provider or pharmacist before using it further or deciding whether to discard it.
The recalled product
- Product
- ACETYLCYSTEINE OPTH 5% Solution, 15 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
- Hazard
- contamination
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: 66017
- BUD: 10/13/2022
- 66177
- BUD: 10/19/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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