January 2018 FDA Recall Drug by Jcb Laboratories Llc
D-0246-2018 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Jcb Laboratories Llc on January 24, 2018 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0246-2018

Reason for Recall
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Initiated
01-24-2018
Reported
02-07-2018
Quantity
6,510 syriges

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78962
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.
JCB Laboratories 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 within USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-03-2020
Product Description About Product Description
Full technical description of the product.
Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205

Batch or Lot Expiration Information

Lot# : C274-000002725, BUD 1/21/2018; C274-000002790, BUD 1/28/2018; C274-000002989, BUD 2/13/2018; C274-000003008, BUD 2/14/2018; C274-000003077, BUD 2/20/2018