METHYLPREDNISOLONE ACETATE Recall D-1061-2022
Description: MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single dose vial (NDC 6714-088-01) b) 25-count box (NDC16714-088-25), Rx only, MFG: NorthstarRx/Teva Pharma USA
METHYLPREDNISOLONE ACETATE Recall D-1061-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1061-2022 |
| Event ID | 89646 |
| Brand | METHYLPREDNISOLONE ACETATE |
| Generic Name | METHYLPREDNISOLONE ACETATE |
| Manufacturer | METHYLPREDNISOLONE ACETATE |
| Original Package? | 1 |
| Active Substance | METHYLPREDNISOLONE ACETATE |
| Drug Route | INTRA-ARTICULAR |
| Distribution | USA nationwide. |
| Quantity | 885 vials |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 16714-088 16714-472 |
| 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 | ANDA040557 |
| Structured Product Labeling (SPL ID) | dc48f3e4-95ae-40a1-951e-1e46a884443f |
| Structured Product Labeling (SPL Set ID) | 40e871a8-98ea-46bd-a593-ab800da186b4 |
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