July 2020 FDA Recall Drug by Edge Pharma, Llc
D-1562-2020 - Labeling

This Class II drug recall was voluntarily initiated by Edge Pharma, Llc on July 2, 2020 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in WI and the recall is currently terminated.

Recall Number: D-1562-2020

Reason for Recall
Labeling: Label Error on Declared Strength
Initiated
07-02-2020
Reported
09-16-2020
Quantity
5 IV bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86324
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.
Edge 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.
WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2023
Product Description About Product Description
Full technical description of the product.
Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01

Batch or Lot Expiration Information

Lot# 06-2020-04@2 BUD 09-16-2020