FDAClass IISeptember 30, 2015

Blephamide recall: Particulate Matter

BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California…

Why was Blephamide recalled?

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 86430, Exp 09/17; 87806, Exp 02/18; 88147, Exp 03/18

Product
BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California…
Recalling firm
Allergan Sales, LLC
Quantity
337 tubes
Distribution
Nationwide, Puerto Rico, and Barbados
Recall date
September 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls