METHYLPREDNISOLONE ACETATE Recall D-1062-2022
Description: MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA , NDC 16714-089-01
METHYLPREDNISOLONE ACETATE Recall D-1062-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1062-2022 |
| Event ID | 89646 |
| Brand | METHYLPREDNISOLONE ACETATE |
| Generic Name | METHYLPREDNISOLONE ACETATE |
| Manufacturer | METHYLPREDNISOLONE ACETATE |
| Original Package? | 1 |
| Active Substance | METHYLPREDNISOLONE ACETATE |
| Drug Route | INTRALESIONAL |
| Distribution | USA nationwide. |
| Quantity | 263 vials |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 16714-089 16714-090 16714-473 |
| 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 | 43502P7F0P |
| Drug Application Number | ANDA040620 |
| Structured Product Labeling (SPL ID) | 177dfcf0-e2ff-48df-a8df-8e5c18481739 |
| Structured Product Labeling (SPL Set ID) | be407d75-c347-4adb-b165-5bd23a0a0fe5 |
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