Drug 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.
D-0574-2020
Product summary
- Event
- Event 84356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 275,060 vials
- Official record key
drug-enforcement:D-0574-2020
Official wording
Reason: Discoloration: Product complaints of discoloration after reconstitution of vials.
Code information: Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Discoloration: Product complaints of discoloration after reconstitution of vials.