Product Safety Recalls

Product Recall Tracker

Recall D-0998-2022

Description: Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10

Recall D-0998-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0998-2022
Event ID89646
BrandPHYSICIANS EZ USE M-PRED
Generic NameMETHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE
ManufacturerMETHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE
Original Package?1
Drug RouteEPIDURAL
DistributionUSA nationwide.
Quantity224 cartons/10 vials each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC76420-520
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
Structured Product Labeling (SPL ID)c8e71330-8128-73d7-e053-2995a90aea8b
Structured Product Labeling (SPL Set ID)dec92845-e713-42a3-83a7-3a48920b7eed
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