ALBUTEROL SULFATE Recall D-1076-2022
Description: Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22
ALBUTEROL SULFATE Recall D-1076-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1076-2022 |
| Event ID | 89646 |
| Brand | PROAIR |
| Generic Name | ALBUTEROL SULFATE |
| Manufacturer | ALBUTEROL SULFATE |
| Original Package? | 1 |
| Active Substance | ALBUTEROL SULFATE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | USA nationwide. |
| Quantity | 56 inhalers |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 59310-579 |
| 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 | 021SEF3731 |
| Drug Application Number | NDA021457 |
| Structured Product Labeling (SPL ID) | 07738d64-2ab5-4f96-bce1-f92bbb93ef18 |
| Structured Product Labeling (SPL Set ID) | 8e701d71-1dcb-4b84-bada-84e4f04f5e62 |
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