FDA Recalls Vancomycin Intravitreal Injections for Sterility Defect
Pharmacy Plus Inc. is recalling vancomycin intravitreal eye injections due to FDA findings that sterility cannot be assured. The products were produced in a manner that does not guarantee they remain sterile.
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 for sterility assurance failure on an intraocular injectable medication. This is a risk-of-harm product where injury has not yet been reported; sterility failure could result in serious infection, but no illnesses or injuries are documented in the source.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling vancomycin intravitreal 1mg/0.1ml solution in 0.5 mL syringes. The FDA conducted an inspection and found that the recalled products were produced in a manner that cannot guarantee the sterility of these injectable solutions, which are required to be sterile.
The affected product is a prescription medication intended for intraocular injection. The recall involves three lots: 65432 (BUD 10/13/2022), 66347 (BUD 11/05/2022), and 66864 (BUD 11/18/2022). A total of twelve syringes were distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Patients who have received injections from these lots should consult their healthcare provider immediately. If you have a package of this product that has not been used, do not use it and contact your pharmacy or Pharmacy Plus, Inc. for return instructions.
The recalled product
- Product
- VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic / Injectable
- Affected units
- 12
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 (6)
- Lots: 65432
- BUD: 10/13/2022
- 66347
- BUD: 11/05/2022
- 66864
- BUD: 11/18/2022
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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