D-0827-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 29, 2021
- Initiation Date
- August 27, 2021
- Termination Date
- October 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 5362 inhalers; b) 5593 inhalers
Product 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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide.
Code Information
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