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08.24.2015 | Products

Allergan Issues Voluntary Nationwide Recall in the U.S. of Specific Lots of REFRESH® Lacri-Lube®, REFRESH P.M. ®, FML® (fluorometholone ophthalmic ointment) 0.1%, and Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% for Particulate Matter

Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use.  This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube, and potentially introduced into the product.   Reported adverse events include Foreign Body in Eye (12), Eye Irritation (2), Ocular Discomfort (2), Product Contamination (2), Superficial Injury of Eye (2), Eye Pain (1), Eye Swelling (1) and Vision Blurred (1).

Specific lots are being voluntarily recalled in the interest of patient safety.  If the particle gets into the eye, potential adverse events may include eye pain, eye swelling, ocular discomfort or eye irritation. Please contact your physician or healthcare provider if you have any of these symptoms when using these products.  The lot number and expiration date may be found on the bottom flap of the carton with the safety seal and on the crimp seal of the product tube.

Specific information on product and lots that are being voluntarily recalled are below
 
NDC Description Lot Number Expiration Date
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 84746 Apr-17
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 84987 May-17
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 85087 May-17
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 85359 Jun-17
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 85721 Jul-17
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 86045 Aug-17
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 86406 Sep-17
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 86594 Oct-17
0023-0312-04 REFRESH® Lacri-Lube® 3.5 g 87021 Nov-17
0023-0312-07 REFRESH® Lacri-Lube® 7g 86470 Sep-17
0023-0312-07 REFRESH® Lacri-Lube® 7g 86829 Oct-17
0023-0312-07 REFRESH® Lacri-Lube® 7g 87105 Nov-17
0023-0240-04 REFRESH P.M.® 3.5 g 85165 May-17
0023-0240-04 REFRESH P.M.® 3.5 g 85228 May-17
0023-0240-04 REFRESH P.M.® 3.5 g 85244 Jun-17
0023-0240-04 REFRESH P.M.® 3.5 g 85351 Jun-17
0023-0240-04 REFRESH P.M.® 3.5 g 85374 Jun-17
0023-0240-04 REFRESH P.M.® 3.5 g 85397 Jun-17
0023-0240-04 REFRESH P.M.® 3.5 g 85561 Jul-17
0023-0240-04 REFRESH P.M.® 3.5 g 85676 Jul-17
0023-0240-04 REFRESH P.M.® 3.5 g 85694 Jul-17
0023-0240-04 REFRESH P.M.® 3.5 g 85834 Aug-17
0023-0240-04 REFRESH P.M.® 3.5 g 85977 Aug-17
0023-0240-04 REFRESH P.M.® 3.5 g 85985 Aug-17
0023-0240-04 REFRESH P.M.® 3.5 g 86073 Aug-17
0023-0240-04 REFRESH P.M.® 3.5 g 85599 Sep-17
0023-0240-04 REFRESH P.M.® 3.5 g 86290 Sep-17
0023-0240-04 REFRESH P.M.® 3.5 g 86325 Sep-17
0023-0240-04 REFRESH P.M.® 3.5 g 86411 Sep-17
0023-0240-04 REFRESH P.M.® 3.5 g 86427 Sep-17
0023-0240-04 REFRESH P.M.® 3.5 g 86506 Sep-17
0023-0240-04 REFRESH P.M.® 3.5 g 86515 Sep-17
0023-0240-04 REFRESH P.M.® 3.5 g 86517 Sep-17
0023-0240-04 REFRESH P.M.® 3.5 g 86746 Oct-17
0023-0240-04 REFRESH P.M.® 3.5 g 86792 Oct-17
0023-0240-04 REFRESH P.M.® 3.5 g 86789 Oct-17
0023-0240-04 REFRESH P.M.® 3.5 g 86809 Oct-17
0023-0240-04 REFRESH P.M.® 3.5 g 86822 Oct-17
0023-0240-04 REFRESH P.M.® 3.5 g 86822A Oct-17
0023-0240-04 REFRESH P.M.® 3.5 g 86932 Nov-17
0023-0240-04 REFRESH P.M.® 3.5 g 87100 Nov-17
0023-0240-04 REFRESH P.M.® 3.5 g 87068 Nov-17
0023-0240-04 REFRESH P.M.® 3.5 g 87156 Dec-17
0023-0240-04 REFRESH P.M.® 3.5 g 87261 Dec-17
0023-0240-04 REFRESH P.M.® 3.5 g 87493 Jan-18
0023-0240-04 REFRESH P.M.® 3.5 g 87494 Feb-18
0023-0240-04 REFRESH P.M.® 3.5 g 87731 Feb-18
0023-0240-04 REFRESH P.M.® 3.5 g  (Professional Sample Pack) 85165 May-17
0023-0240-04 REFRESH P.M.® 3.5 g (Professional Sample Pack) 86789 Oct-17
0023-0316-04 FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g 86258 Sep-16 *
0023-0316-04 FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g 87189 Dec-16 **
0023-0316-04 FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g 87514 Feb-17 ***
0023-0313-04 Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g 86430 Sep-17
0023-0313-04 Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g 87806 Feb-18
0023-0313-04 Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g 88147 Mar-18
 
* Corrected date. Previously reported as "Sep-17".
** Corrected date. Previously reported as "Dec-17".
*** Corrected date. Previously reported as "Feb-18".

Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. The recall only applies to specific lots of the REFRESH® Lacri-Lube®, REFRESH P.M. ®,  FML® (fluorometholone ophthalmic ointment) 0.1%, Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%.  This recall does not affect any other REFRESH or Allergan product.  

Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product. 

The company is asking consumers who currently have product from any of the affected  lots of REFRESH® Lacri-Lube®, REFRESH P.M. ®,  FML® (fluorometholone ophthalmic ointment) 0.1% , Blephamide® (sulfacetamide sodium or prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, to stop using the product and return it to Allergan. 

If there are questions or if assistance is required in response to this recall, please use the contact information below. 

 
CONTACT INFORMATION
Product Returns
Contact GENCO at:
877-674-2087
7 am to 5 pm CST
Credit/Reimbursements
Contact Allergan at:
1-800-811-4148
7am to 5pm PST
Allergan
Medical Inquiries:
1-800-433-8871 option 2 8am - 5pm PST
Adverse Events/Product Complaints:
1-800-624-4261 Option 3 (8am – 5pm CST
FDA contact information for reporting adverse events/quality complaints:
Online at www.fda.gov/medwatch/report.htm or call FDA at 1-800-FDA-1088

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this product. 


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(973) 906-1526
        
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For local media contacts in other countries, please visit the relevant country website.

Investor relations:

Christine Chiou
Investor Relations
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