PROPOFOL Recall D-1078-2022
Description: Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95
PROPOFOL Recall D-1078-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1078-2022 |
| Event ID | 89646 |
| Brand | PROPOFOL |
| Generic Name | PROPOFOL |
| Manufacturer | PROPOFOL |
| Original Package? | 1 |
| Active Substance | PROPOFOL |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide. |
| Quantity | 564 cartons/25 vials each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0591-2136 |
| Product NUI | N0000175975 N0000175681 |
| Pharma Class (PE) | General Anesthesia [PE] |
| Pharma Class (EPC) | General Anesthetic [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 | YI7VU623SF |
| Drug Application Number | ANDA205307 |
| Structured Product Labeling (SPL ID) | 08798d87-7c60-429d-bf0b-fcc6f93fddaa |
| Structured Product Labeling (SPL Set ID) | 6f8bebf9-d87b-469a-911a-21135ba841ae |
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