CEFAZOLIN SODIUM Recall D-1118-2022
Description: Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3105-11
CEFAZOLIN SODIUM Recall D-1118-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1118-2022 |
| Event ID | 89646 |
| Brand | CEFAZOLIN SODIUM |
| Generic Name | CEFAZOLIN SODIUM |
| Manufacturer | CEFAZOLIN SODIUM |
| Original Package? | 1 |
| Active Substance | CEFAZOLIN SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide. |
| Quantity | 39 cases |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0264-3103 0264-3105 |
| 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 | P380M0454Z |
| Drug Application Number | NDA050779 |
| Structured Product Labeling (SPL ID) | 77c1e04e-d104-4906-8e80-d77756d9db2f |
| Structured Product Labeling (SPL Set ID) | 17f8f038-c204-4dab-80d7-6f7ac41ddbec |
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