APREPITANT Recall D-1027-2022
Description: Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG: Sandoz Pharma, NDC 0781-2321-06
APREPITANT Recall D-1027-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1027-2022 |
| Event ID | 89646 |
| Brand | APREPITANT |
| Generic Name | APREPITANT |
| Manufacturer | APREPITANT |
| Original Package? | 1 |
| Active Substance | APREPITANT |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 29 boxes |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0781-2321 0781-2322 0781-4063 |
| Product NUI | N0000010262 N0000175786 N0000182141 |
| Pharma Class (EPC) | Substance P/Neurokinin-1 Receptor Antagonist [EPC] |
| 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 | 1NF15YR6UY |
| Drug Application Number | ANDA090999 |
| Structured Product Labeling (SPL ID) | fabed213-6059-4862-b09a-38718218a303 |
| Structured Product Labeling (SPL Set ID) | f58b8944-93ee-4be1-a238-cc0061ddd93a |
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