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.

Class I - Dangerous
💊 Drugs Recalled: August 24, 2015 Allergan Sales Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 86430, Exp 09/17; 87806, Exp 02/18; 88147, Exp 03/18
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Allergan Sales, LLC
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1820-2015

Related Recalls