Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
  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:
Nephron Pharmaceuticals Corp.
Reason for Recall:
Lack of Assurance of Sterility
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.

Product Codes/Lot Numbers:

Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1446-2012

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Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.

Nov 16, 2015 Other Medical Devices Nationwide View Details →