Reported Sep 29, 2021 · Terminated

Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark…

Glenmark Pharmaceuticals Inc., USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

  • Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral
  • Inhalation Only Rx Only Manufactured byGlenmark Pharmaceuticals Inc., USA Monroe
  • NC 28110 Manufactured forGlenmark 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
Lot codes and dates
  • 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
Amount recalled
a) 5362 inhalers; b) 5593 inhalers

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Glenmark Pharmaceuticals Inc., USA recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 4, 2023 · Data as of Sep 19, 8:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.