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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1095-2022
Event ID89646
BrandBUPIVACAINE HYDROCHLORIDE
Generic NameBUPIVACAINE HYDROCHLORIDE
ManufacturerBUPIVACAINE HYDROCHLORIDE
Original Package?1
Active SubstanceBUPIVACAINE HYDROCHLORIDE
Drug RouteEPIDURAL
DistributionUSA nationwide.
Quantity30 vials
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0409-1159 0409-1160 0409-1162
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier30Q7KI53AK 7TQO7W3VT8
Drug Application NumberANDA070583
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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