January 2019 FDA Recall Bromsite by Sun Pharmaceutical Industries, Inc. (D-0422-2019 - Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.)

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on January 24, 2019 for the product Bromsite. The FDA reported the reason for recall as bromfenac ophthalmic solution, 0.075% (sterile 5 ml) may have a lack of sterility assurance.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0422-2019

Reason for Recall
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Initiated
01-24-2019
Reported
02-06-2019
Quantity
69840 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81958
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.
Sun Pharmaceutical Industries, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2021
Product Description About Product Description
Full technical description of the product.
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41

Batch or Lot Expiration Information

Lot# : V18E01, Exp. 05/2020

Affected Packages Involved in this Recall

49708-754-41 Bromsite 0.075%