Vancomycin Eye Drops Recalled for Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all lots of Vancomycin (fortified) 25mg/ml ophthalmic solution due to quality control issues affecting sterility assurance.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. The hazard involves a lack of sterility assurance in a sterile compounded product, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk structural/quality defects.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all lots of Vancomycin (fortified) 25mg/ml ophthalmic solution. The recall includes all lots within their expiration dates. The distribution pattern is listed as NC.
The recall was initiated due to a lack of sterility assurance. This was identified following a recent FDA inspection that observed concerns associated with quality control procedures. These procedures present a potential risk to the sterility of the compounded sterile products.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The source text does not specify a specific number of affected units or reported illnesses.
The recalled product
- Product
- Vancomycin (fortified) 25mg/ml opth
- Manufacturer
- Natures Pharmacy & Compounding Center
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 (1)
- All lot numbers within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 48 recalled by Natures Pharmacy & Compounding Center 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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