BUPIVACAINE HYDROCHLORIDE Recall D-1095-2022
Description: Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01
BUPIVACAINE HYDROCHLORIDE Recall D-1095-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1095-2022 |
| Event ID | 89646 |
| Brand | BUPIVACAINE HYDROCHLORIDE |
| Generic Name | BUPIVACAINE HYDROCHLORIDE |
| Manufacturer | BUPIVACAINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | BUPIVACAINE HYDROCHLORIDE |
| Drug Route | EPIDURAL |
| Distribution | USA nationwide. |
| Quantity | 30 vials |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0409-1159 0409-1160 0409-1162 |
| 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 | 30Q7KI53AK 7TQO7W3VT8 |
| Drug Application Number | ANDA070583 |
| Structured Product Labeling (SPL ID) | 2bc0767c-c6ba-42d6-8a30-2084200d187c |
| Structured Product Labeling (SPL Set ID) | 02a845c3-4521-4926-e397-25ab536e7cf6 |
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