January 2016 FDA Recall Drug by Mayne Pharma Usa
D-0585-2016 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Mayne Pharma Usa on January 5, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0585-2016

Reason for Recall
Lack of Assurance of Sterility: Failed preservative effectiveness test
Initiated
01-05-2016
Reported
01-27-2016
Quantity
a) 52034 bottles and b) 22074 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73072
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.
Mayne Pharma Usa
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2017
Product Description About Product Description
Full technical description of the product.
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505

Batch or Lot Expiration Information

Lot# a) Lot numbers: 0378-7110-35 AD4819, Exp. Date: 08-2016; 0378-7110-35 AC7894, Exp. Date: 05-2016; 0378-7110-35 AD2527, Exp. Date: 06-2016; 0378-7110-35 AC6330, Exp. Date: 05-2016; 0378-7110-35 AC2330, Exp. Date: 04-2016 and b) Lot numbers: 0378-7109-35 AD4515, Exp. Date: 04-2016 and 0378-7109-35 AC2328, Exp. Date: 01-2016.