Recalls / Class II
Class IID-0574-2020
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 name
- Vancomycin Hydrochloride
- Generic name
- Vancomycin Hydrochloride
- Active ingredient
- Vancomycin Hydrochloride
- Route
- Intravenous
- NDCs
- 55150-203, 55150-204
- FDA application
- ANDA205780
- Affected lot / code info
- Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
Why it was recalled
Discoloration: Product complaints of discoloration after reconstitution of vials.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 275,060 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-11-25
- FDA classified
- 2019-12-06
- Posted by FDA
- 2019-12-18
- Terminated
- 2021-03-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0574-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.