November 2019 FDA Recall Vancomycin Hydrochloride by Auromedics Pharma Llc
D-0574-2020 - Discoloration

This Class II drug recall was voluntarily initiated by Auromedics Pharma Llc on November 25, 2019 for the product Vancomycin Hydrochloride. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0574-2020

Reason for Recall
Discoloration: Product complaints of discoloration after reconstitution of vials.
Initiated
11-25-2019
Reported
12-18-2019
Quantity
275,060 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84356
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AuroMedics Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-04-2021
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# : CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020

Affected Packages Involved in this Recall

55150-203-10 Vancomycin Hydrochloride
55150-204-20 Vancomycin Hydrochloride