The Recall Desk
ModerateFDA (Drugs)·D-1820-2015·Announced 2015-09-30

Allergan Recalls Blephamide Ophthalmic Ointment Due to Particulate Matter

Allergan is recalling 337 tubes of Blephamide ophthalmic ointment because small black particles from the tube cap may be present in the product.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves physical particulate matter from the packaging cap, which is a quality defect rather than a high-risk biological pathogen or structural defect causing severe injury.

Plain-English summary

Allergan Sales, LLC is recalling 337 tubes of Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g tube. The recall is due to customer complaints regarding the presence of small black particles in the product.

The particles were identified as part of the ointment tube cap. They are generated by the action of unscrewing the cap from the aluminum tube and may be introduced into the product. The affected lots are 86430 (Exp 09/17), 87806 (Exp 02/18), and 88147 (Exp 03/18).

The product was distributed nationwide, in Puerto Rico, and in Barbados. Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9.
Manufacturer
Allergan Sales, LLC
Category
Drug — Ophthalmic Ointment
Hazard
Affected units
337

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Allergan Sales, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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