MEDROXYPROGESTERONE ACETATE Recall D-1060-2022
Description: Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx only, MFG: NorthStarRx/Teva Pharma USA , NDC 16714-981-01
MEDROXYPROGESTERONE ACETATE Recall D-1060-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1060-2022 |
| 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 | 780 vials |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 16714-981 |
| 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 | ANDA210760 |
| Structured Product Labeling (SPL ID) | 72bfa421-1b70-4cc4-a366-771028b02cff |
| Structured Product Labeling (SPL Set ID) | 7cc31691-8268-4e59-b645-19246931f03c |
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