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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 2
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
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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