February 2019 FDA Recall Drug by Leiter's Enterprises, Inc.
D-0518-2019 - Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.

This Class II drug recall was voluntarily initiated by Leiter's Enterprises, Inc. on February 19, 2019 for the product Drug. The FDA reported the reason for recall as incorrect product formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% sodium chloride.. The product was distributed in CA, AZ, MI, NY and the recall is currently terminated.

Recall Number: D-0518-2019

Reason for Recall
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Initiated
02-19-2019
Reported
03-13-2019
Quantity
569 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82229
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.
Leiter's Enterprises, Inc.
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, AZ, MI, NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2020
Product Description About Product Description
Full technical description of the product.
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35.

Batch or Lot Expiration Information

Lot# 1811195, Exp. Date: 05/01/19