LEVALBUTEROL TARTRATE Recall D-1067-2022
Description: Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54
LEVALBUTEROL TARTRATE Recall D-1067-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1067-2022 |
| Event ID | 89646 |
| Brand | LEVALBUTEROL TARTRATE HFA INHALATION |
| Generic Name | LEVALBUTEROL TARTRATE |
| Manufacturer | LEVALBUTEROL TARTRATE |
| Original Package? | 1 |
| Active Substance | LEVALBUTEROL TARTRATE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 2 inhalers |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0591-2927 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | ADS4I3E22M |
| Drug Application Number | NDA021730 |
| Structured Product Labeling (SPL ID) | c202555a-0ee9-4534-bfef-22a3a9da64e0 |
| Structured Product Labeling (SPL Set ID) | ac85703a-17a2-4f0b-87f4-78f1756d2f85 |
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