Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

Class I - Dangerous
💊 Drugs Recalled: June 15, 2011 Apotex Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
  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:
Apotex Corp.
Reason for Recall:
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

Product Codes/Lot Numbers:

Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1667-2012

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