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. 03/31/202330210045 Exp. 04/30/202330210046 Exp. 04/30/202330210050 Exp. 03/31/202330210051 Exp. 04/30/202330210058 Exp. 04/30/2023b) 30210042 Exp. 03/31/202330210047 Exp. 04/30/202330210048 Exp. 04/30/202330210052 Exp. 04/30/202330210053 Exp. 04/30/202330210054 Exp. 04/30/202330210059 Exp. 04/30/202330210060 Exp. 04/30/202330210061 Exp. 04/30/202330210062 Exp. 04/30/202330210063 Exp. 04/30/202330210064 Exp. 05/31/2023
- Lots
- 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.
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