Refresh Pm Eye Ointment Recall

Allergan plc, a Dublin-based pharmaceutical company, has issued a voluntary recall of specific lots of several of its dry eye and ophthalmic ointment products. The recall applies to the following products: REFRESH® Lacri-Lube® 3.5g and 7g for dry eye, REFRESH P.M.® 3.5g for dry eye, FML® (fluorometholone ophthalmic ointment) 0.1%, and Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%. The recall has been initiated as a precautionary measure, to ensure the safety of customers who may have purchased the affected products. The company is taking immediate steps to remove the impacted products from distribution and is working closely with regulatory authorities to resolve the issue as quickly as possible.

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).

The voluntary recall has been initiated as a precautionary measure to ensure patient safety. In the event that a particle from the affected products enters the eye, patients may experience eye pain, swelling, discomfort, or irritation. Customers who have purchased the products are advised to check the lot number and expiration date, which can be found on the bottom flap of the carton with the safety seal and on the crimp seal of the product tube. If any of the aforementioned symptoms are experienced while using these products, patients should contact their healthcare provider immediately. The company is committed to ensuring the highest standards of product quality and is taking all necessary steps to address the issue and minimize any potential harm to patients.

Here are the specific details regarding the products and batches that are subject to the voluntary recall.

NDCDescriptionLot NumberExpiration Date
0023-0312-04REFRESH® Lacri-Lube® 3.5 g84746Apr- 17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g84987May- 17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85087May- 17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85359Jun- 17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85721Jul- 17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86045Aug- 17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86406Sep-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86594Oct- 17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g87021Nov- 17
0023-0312-07REFRESH® Lacri-Lube® 7g86470Sep- 17
0023-0312-07REFRESH® Lacri-Lube® 7g86829Oct- 17
0023-0312-07REFRESH® Lacri-Lube® 7g87105Nov- 17
0023-0240-04REFRESH P.M.® 3.5 g85165May- 17
0023-0240-04REFRESH P.M.® 3.5 g85228May- 17
0023-0240-04REFRESH P.M.® 3.5 g85244Jun- 17
0023-0240-04REFRESH P.M.® 3.5 g85351Jun- 17
0023-0240-04REFRESH P.M.® 3.5 g85374Jun- 17
0023-0240-04REFRESH P.M.® 3.5 g85397Jun- 17
0023-0240-04REFRESH P.M.® 3.5 g85561Jul- 17
0023-0240-04REFRESH P.M.® 3.5 g85676Jul- 17
0023-0240-04REFRESH P.M.® 3.5 g85694Jul- 17
0023-0240-04REFRESH P.M.® 3.5 g85834Aug- 17
0023-0240-04REFRESH P.M.® 3.5 g85977Aug- 17
0023-0240-04REFRESH P.M.® 3.5 g85985Aug- 17
0023-0240-04REFRESH P.M.® 3.5 g86073Aug- 17
0023-0240-04REFRESH P.M.® 3.5 g85599Sep- 17
0023-0240-04REFRESH P.M.® 3.5 g86290Sep- 17
0023-0240-04REFRESH P.M.® 3.5 g86325Sep- 17
0023-0240-04REFRESH P.M.® 3.5 g86411Sep- 17
0023-0240-04REFRESH P.M.® 3.5 g86427Sep- 17
0023-0240-04REFRESH P.M.® 3.5 g86506Sep- 17
0023-0240-04REFRESH P.M.® 3.5 g86515Sep- 17
0023-0240-04REFRESH P.M.® 3.5 g86517Sep- 17
0023-0240-04REFRESH P.M.® 3.5 g86746Oct- 17
0023-0240-04REFRESH P.M.® 3.5 g86809Oct- 17
0023-0240-04REFRESH P.M.® 3.5 g86789Oct- 17
0023-0240-04REFRESH P.M.® 3.5 g86809Oct- 17
0023-0240-04REFRESH P.M.® 3.5 g86822Oct- 17
0023-0240-04REFRESH P.M.® 3.5 g86822AOct- 17
0023-0240-04REFRESH P.M.® 3.5 g87068Nov- 17
0023-0240-04REFRESH P.M.® 3.5 g87100Nov- 17
0023-0240-04REFRESH P.M.® 3.5 g87068Nov- 17
0023-0240-04REFRESH P.M.® 3.5 g87156Dec- 17
0023-0240-04REFRESH P.M.® 3.5 g87261Dec- 17
0023-0240-04REFRESH P.M.® 3.5 g87493Jan- 18
0023-0240-04REFRESH P.M.® 3.5 g87494Feb- 18
0023-0240-04REFRESH P.M.® 3.5 g87731Feb- 18
0023-0316-04REFRESH P.M.® 3.5 g  (Professional Sample Pack)85165May- 17
0023-0316-04REFRESH P.M.® 3.5 g (Professional Sample Pack)86789Oct- 17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g86258Sep- 17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g87189Dec- 17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g87514Feb- 18
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic oinment, UPS) 10%/0.2%, 3.5g86430Sep-17
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic oinment, UPS) 10%/0.2%, 3.5g87806Feb- 18
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic oinment, UPS) 10%/0.2%, 3.5g88147Mar-18

Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. The scope of the recall is limited to certain batches of the products, namely, 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%. This recall is specific to these products and does not have any impact on the availability or distribution of any other product offered by the manufacturer.

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. 

Allergan is urging consumers who have purchased any of the affected products to discontinue their use immediately and return them to the company. The affected products are REFRESH® Lacri-Lube®, REFRESH P.M. ®, FML® (fluorometholone ophthalmic ointment) 0.1%, and Blephamide® (sulfacetamide sodium or prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, which are identified by their lot number and expiration date. To facilitate the return process, the company is providing instructions on its website and has established a dedicated hotline for customers to call with any questions or concerns. Allergan takes the safety and well-being of its customers seriously and is committed to resolving the issue as quickly and efficiently as possible.

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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