Reported Dec 18, 2019 · Terminated
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in…
AuroMedics Pharma LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AuroMedics Pharma LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft
- in India forAuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20
- Lot codes and dates
Lot #: CVM180003CVM180004Exp 04/2020CVM180008Exp 07/2020CVM180009CVM180010CVM180011CVM180012Exp 09/2020
- Amount recalled
- 275,060 vials
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Discoloration: Product complaints of discoloration after reconstitution of vials.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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