ALBUTEROL SULFATE Recall D-1090-2022
Description: Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only, MFG: Merck Company, NDC 0085-1132-04
ALBUTEROL SULFATE Recall D-1090-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1090-2022 |
| Event ID | 89646 |
| Brand | PROVENTIL HFA |
| Generic Name | ALBUTEROL SULFATE |
| Manufacturer | ALBUTEROL SULFATE |
| Original Package? | 1 |
| Active Substance | ALBUTEROL SULFATE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | USA nationwide. |
| Quantity | 22 inhalers |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0085-1132 |
| 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 | NDA020503 |
| Structured Product Labeling (SPL ID) | bd0c720f-c140-401e-e053-2a95a90a970d |
| Structured Product Labeling (SPL Set ID) | 0f8fd0fb-97bc-479e-a9e9-104ea7b230e7 |
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