🔍 RecallPedia

Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35

Class I - Dangerous
💊 Drugs Recalled: August 27, 2021 Glenmark Pharmaceuticals Inc., USA Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: a) 30210041 Exp. 03/31/2023; 30210045 Exp. 04/30/2023; 30210046 Exp. 04/30/2023; 30210050 Exp. 03/31/2023; 30210051 Exp. 04/30/2023; 30210058 Exp. 04/30/2023; b) 30210042 Exp. 03/31/2023; 30210047 Exp. 04/30/2023; 30210048 Exp. 04/30/2023; 30210052 Exp. 04/30/2023; 30210053 Exp. 04/30/2023; 30210054 Exp. 04/30/2023; 30210059 Exp. 04/30/2023; 30210060 Exp. 04/30/2023; 30210061 Exp. 04/30/2023; 30210062 Exp. 04/30/2023; 30210063 Exp. 04/30/2023; 30210064 Exp. 05/31/2023
  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:
Glenmark Pharmaceuticals Inc., USA
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:

Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35

Product Codes/Lot Numbers:

Lots: a) 30210041 Exp. 03/31/2023; 30210045 Exp. 04/30/2023; 30210046 Exp. 04/30/2023; 30210050 Exp. 03/31/2023; 30210051 Exp. 04/30/2023; 30210058 Exp. 04/30/2023; b) 30210042 Exp. 03/31/2023; 30210047 Exp. 04/30/2023; 30210048 Exp. 04/30/2023; 30210052 Exp. 04/30/2023; 30210053 Exp. 04/30/2023; 30210054 Exp. 04/30/2023; 30210059 Exp. 04/30/2023; 30210060 Exp. 04/30/2023; 30210061 Exp. 04/30/2023; 30210062 Exp. 04/30/2023; 30210063 Exp. 04/30/2023; 30210064 Exp. 05/31/2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0827-2021

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