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.

FDA recall notice · announced December 18, 2019 · Auromedics Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Discoloration: Product complaints of discoloration after reconstitution of vials.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020
Quantity: 275,060 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.