ALBUTEROL SULFATE Recall D-1018-2022
Description: Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron Pharma, NDC 0487-0301-01
ALBUTEROL SULFATE Recall D-1018-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1018-2022 |
| 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 | 1 carton/30 pouches each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0487-0301 0487-9904 |
| Drug UPC | 0304879904019 0304870301015 |
| 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 | ANDA076355 |
| Structured Product Labeling (SPL ID) | b8a6cb0d-0000-5734-e053-2995a90abd12 |
| Structured Product Labeling (SPL Set ID) | 285a656c-f77f-4e77-b0a8-a0e9c901803f |
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