Vancomycin Hydrochloride Injection (AuroMedics) – Discoloration Issue (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.
Brand
AuroMedics Pharma LLC
Lot Codes / Batch Numbers
Lot #: CVM180003, CVM180004, Exp 04/2020, CVM180008, Exp 07/2020, CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
Products Sold
Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
AuroMedics Pharma LLC is recalling Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, R due to Discoloration: Product complaints of discoloration after reconstitution of vials.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Discoloration: Product complaints of discoloration after reconstitution of vials.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026