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PYRIDOSTIGMINE BROMIDE Recall D-0018-2023

Description: Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01

PYRIDOSTIGMINE BROMIDE Recall D-0018-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0018-2023
Event ID90943
BrandPYRIDOSTIGMINE BROMIDE
Generic NamePYRIDOSTIGMINE BROMIDE
ManufacturerPYRIDOSTIGMINE BROMIDE
Active SubstancePYRIDOSTIGMINE BROMIDE
Drug RouteORAL
DistributionUSA Nationwide
Quantity1980 cups
Recall ReasoncGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Drug ClassificationClass II
Drug Code Info20221102
Product NDC66689-406
Recall Initiation Date20220930
Report Date20221102
Classification Date20221021
Address7265 Ulmerton Rd
Largo, FL 33771-4809
United States
Recalling FirmVistaPharm, Inc.
Initial Notification Letter
Unique Ingredient IdentifierKVI301NA53
Drug Application NumberANDA211694
Structured Product Labeling (SPL ID)be11a5b5-9644-4e47-b464-9b51a00a46a9
Structured Product Labeling (SPL Set ID)9ab2ece0-7c0d-4045-a9f1-447aa97d623e
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