Recalls / Class II

Class IID-0827-2021

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; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35

Affected lot / code info

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

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Glenmark Pharmaceuticals Inc., USA

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

750 Corporate Dr, Mahwah, New Jersey 07430-2009

Distribution

Quantity

a) 5362 inhalers; b) 5593 inhalers

Distribution pattern

Nationwide.

Timeline

Recall initiated

2021-08-27

FDA classified

2021-09-21

Posted by FDA

2021-09-29

Terminated

2023-10-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0827-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.