AuroMedics Recalls Vancomycin Hydrochloride Vials Due to Discoloration
AuroMedics Pharma LLC is recalling specific lots of Vancomycin Hydrochloride for Injection due to reports of discoloration after reconstitution.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a quality defect (discoloration) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
AuroMedics Pharma LLC is recalling 275,060 vials of Vancomycin Hydrochloride for Injection, USP, 1 g per vial. The product is packaged in 10-count vials per carton and is available by prescription only. The affected lots are CVM180003, CVM180004, CVM180008, CVM180009, CVM180010, CVM180011, and CVM180012, with expiration dates ranging from April 2020 to September 2020.
The recall was initiated due to product complaints regarding discoloration observed after the reconstitution of the vials. The product was distributed nationwide in the USA.
Healthcare providers and patients should stop using the affected lots and contact AuroMedics Pharma LLC for further instructions or a replacement.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Antibiotic Injection
- Affected units
- 275,060
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 (10)
- Lot #: CVM180003
- CVM180004
- Exp 04/2020
- CVM180008
- Exp 07/2020
- CVM180009
- CVM180010
- CVM180011
- CVM180012
- Exp 09/2020
Distribution
Distributed nationwide across the United States.
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