Acetylcysteine eye drops recalled for sterility assurance defect
Pharmacy Plus Inc. is recalling acetylcysteine 10% eye drop solution due to manufacturing issues that cannot guarantee sterility. Lot 66895 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 involves a sterile pharmaceutical product with unassured sterility, presenting potential risk of microbial infection. This qualifies as High (3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling acetylcysteine ophthalmic 10% solution (eye drops) in 15 mL droptainers. The FDA inspection found that the products were manufactured in a manner that cannot guarantee the sterility of these medications, which are required to be sterile.
The recalled product is lot 66895 with a beyond-use date of November 19, 2022. Distribution was limited to Alabama, Louisiana, Mississippi, and Tennessee.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- ACETYLCYSTEINE OPTH 10% 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 / Eye Drops
- Affected units
- 1
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 (2)
- Lot: 66895
- BUD: 11/19/2022
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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