METHYLPREDNISOLONE ACETATE Recall D-1097-2022
Description: Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer
METHYLPREDNISOLONE ACETATE Recall D-1097-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1097-2022 |
| Event ID | 89646 |
| Brand | DEPO-MEDROL |
| Generic Name | METHYLPREDNISOLONE ACETATE |
| Manufacturer | METHYLPREDNISOLONE ACETATE |
| Original Package? | 1 |
| Active Substance | METHYLPREDNISOLONE ACETATE |
| Drug Route | INTRA-ARTICULAR |
| Distribution | USA nationwide. |
| Quantity | 177 cartons |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0009-3073 0009-3475 |
| Drug UPC | 0300093073036 |
| 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 | NDA011757 |
| Structured Product Labeling (SPL ID) | b2eabec8-4fae-4441-b4dd-9a01b0f91c4a |
| Structured Product Labeling (SPL Set ID) | 9a7b3837-e038-48bf-97e9-78ad463760dc |
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