Glycerin Ophthalmic Drops Recalled Due to Sterility Manufacturing Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Glycerin Ophthalmic Drops 98.5% Solution because manufacturing methods cannot guarantee the sterility of the product. Products affected are 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: This is an FDA Class II recall for a prescription ophthalmic medication with confirmed manufacturing control deficiencies that cannot assure sterility. No illnesses or injuries have been reported. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder has recalled Glycerin Ophthalmic Drops 98.5% Solution, a prescription eye medication. The recall was initiated after an FDA inspection determined that the products were manufactured in a manner that cannot assure sterility.
The recalled product is a 10 mL droptainer with lot number 65416 and a Beyond-Use Date of 10/13/2022. It was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
If you have this product, contact your pharmacist or healthcare provider for guidance. Do not use the product.
The recalled product
- Product
- GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- 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: 65416
- BUD: 10/13/2022
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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