December 2020 FDA Recall Drug by Edge Pharma, Llc
D-0307-2021 - Labeling

This Class III drug recall was voluntarily initiated by Edge Pharma, Llc on December 22, 2020 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in PA only and the recall is currently terminated.

Recall Number: D-0307-2021

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Initiated
12-22-2020
Reported
03-24-2021
Quantity
60 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87514
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
PA only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2021
Product Description About Product Description
Full technical description of the product.
Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

Batch or Lot Expiration Information

Lot# : 10-2020-13@8, exp. date 12/03/2020