The Recall Desk
SevereFDA (Drugs)·D-0827-2021·Announced 2021-09-29

Arformoterol Tartrate Inhalation Solution Recall Due to Sterility Assurance

Glenmark Pharmaceuticals is recalling Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL nationwide because the manufacturer lacks assurance of sterility for affected lots.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall. Lack of sterility assurance in an inhalation solution—a prescription drug administered directly to the lungs—creates a significant risk of infection and potential need for hospitalization, meeting the Severe classification criterion.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL for oral inhalation (prescription only). The recall affects two package sizes: 60x2 mL sterile unit-dose vials (NDC 68462-833-65) and 30x2 mL sterile unit-dose vials (NDC 68462-833-35). A total of 5,362 inhalers of the 60x2 mL package and 5,593 inhalers of the 30x2 mL package are affected.

The manufacturer has determined that it cannot assure sterility for the affected lots. The recalled lots include: for the 60x2 mL package, lots 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), and 30210058 (exp. 04/30/2023); for the 30x2 mL package, lots 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), and 30210064 (exp. 05/31/2023). The product was distributed nationwide.

Patients using affected lots should contact their healthcare provider or pharmacy. Healthcare providers and patients should stop use of affected lots immediately and not use the product.

The recalled product

Product
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;
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Inhalation Solution
Hazard
  • sterility-assurance
  • infection-risk

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 (18)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category