MEDROXYPROGESTERONE ACETATE Recall D-1069-2022
Description: Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), Rx only, MFG: Teva Pharma USA
MEDROXYPROGESTERONE ACETATE Recall D-1069-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1069-2022 |
| Event ID | 89646 |
| Brand | MEDROXYPROGESTERONE ACETATE |
| Generic Name | MEDROXYPROGESTERONE ACETATE |
| Manufacturer | MEDROXYPROGESTERONE ACETATE |
| Original Package? | 1 |
| Active Substance | MEDROXYPROGESTERONE ACETATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | USA nationwide. |
| Quantity | 89 cartons/25 vials per carton and 3 cartons/1 vial |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0703-6801 |
| 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 | C2QI4IOI2G |
| Drug Application Number | ANDA076553 |
| Structured Product Labeling (SPL ID) | fdb50b73-14ad-4e17-8730-8bee0f81a5d0 |
| Structured Product Labeling (SPL Set ID) | d279981c-e9e4-4989-bafb-1e184a6d3dd2 |
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