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CLONIDINE HYDROCHLORIDE Recall D-1091-2022

Description: Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10

CLONIDINE HYDROCHLORIDE Recall D-1091-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1091-2022
Event ID89646
BrandDURACLON
Generic NameCLONIDINE HYDROCHLORIDE
ManufacturerCLONIDINE HYDROCHLORIDE
Original Package?1
Active SubstanceCLONIDINE HYDROCHLORIDE
Drug RouteEPIDURAL
DistributionUSA nationwide.
Quantity9 vials
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC67457-218
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 IdentifierW76I6XXF06
Drug Application NumberNDA020615
Structured Product Labeling (SPL ID)671a0224-c38b-4f2e-a132-fa38aa1a0797
Structured Product Labeling (SPL Set ID)8c126bb8-732a-4949-8754-2f50b5543638
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