FDA Drug recall D-0827-2021
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA…
- FDA Drug
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA… by Glenmark Pharmaceuticals Usa, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0827-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-27 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: a) 30210041 Exp. 03/31/2023; 30210045 Exp. 04/30/2023; 30210046 Exp. 04/30/2023; 30210050 Exp. 03/31/2023; 302100…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0827-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.