METHYLPREDNISOLONE ACETATE Recall D-1071-2022
Description: MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), 5 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0043-01
METHYLPREDNISOLONE ACETATE Recall D-1071-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1071-2022 |
| 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 | 65 cartons/1 vial each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0703-0043 0703-0045 0703-0063 |
| 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) | 57a4e988-2e4a-4615-a3f7-7ef65abd0e16 |
| Structured Product Labeling (SPL Set ID) | 769cc1ae-bdf4-47e4-9a9f-c6327bd7dbf4 |
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