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IPRATROPIUM BROMIDE Recall D-1040-2022

Description: Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, MFG: Nephron Pharma, NDC 0487-9801-25

IPRATROPIUM BROMIDE Recall D-1040-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1040-2022
Event ID89646
BrandIPRATROPIUM BROMIDE
Generic NameIPRATROPIUM BROMIDE
ManufacturerIPRATROPIUM BROMIDE
Original Package?1
Active SubstanceIPRATROPIUM BROMIDE
Drug RouteRESPIRATORY (INHALATION)
DistributionUSA nationwide.
Quantity57 pouches
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0487-9801
Drug UPC0304879801011
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 IdentifierJ697UZ2A9J
Drug Application NumberANDA075562
Structured Product Labeling (SPL ID)b8a6d890-6561-40e9-e053-2a95a90a0d61
Structured Product Labeling (SPL Set ID)db8095db-d1fd-4099-9fb1-d1ad4e284976
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