Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral… — Class II drug recall D-0827-2021
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2021-09-29, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0827-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2021-08-27 |
| Classified | 2021-09-21 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2023-10-04 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 68462-0833-35, 68462-0833-65 |
| Expiration dates | 2023-03-31, 2023-04-30, 2023-05-31 |
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 for recall
Lack of Assurance of Sterility
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.