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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