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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