ALBUTEROL SULFATE Recall D-1019-2022
Description: Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03
ALBUTEROL SULFATE Recall D-1019-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1019-2022 |
| Event ID | 89646 |
| Brand | ALBUTEROL SULFATE |
| Generic Name | ALBUTEROL SULFATE |
| Manufacturer | ALBUTEROL SULFATE |
| Original Package? | 1 |
| Active Substance | ALBUTEROL SULFATE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | USA nationwide. |
| Quantity | 23 pouches |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0487-9501 |
| Drug UPC | 0304879501003 0304879501010 |
| 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 | ANDA074880 |
| Structured Product Labeling (SPL ID) | b8a75428-95af-d867-e053-2a95a90a6509 |
| Structured Product Labeling (SPL Set ID) | 574824f3-51cc-4b94-9c10-e3204d8b19f8 |
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