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

News provided by

Allergan plc

Aug 24, 2015, 08:35 ET

DUBLIN, Aug. 24, 2015 /PRNewswire/ -- Allergan plc, today announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH® Lacri-Lube® 3.5g and 7g  for dry eye, REFRESH P.M.® 3.5g for dry eye, FML® (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. 

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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 from unscrewing the cap of 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-17

0023-0316-04

FML® (fluorometholone ophthalmic
ointment) 0.1%, 3.5 g

87189

Dec-17

0023-0316-04

FML® (fluorometholone ophthalmic
ointment) 0.1%, 3.5 g

87514

Feb-18

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

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.

CONTACTS:

Investors:
Lisa DeFrancesco
(862) 261-7152

Media:
Mark Marmur
(973) 906-1526

SOURCE Allergan plc