Product Safety Recalls

Product Recall Tracker

PRAZOSIN HYDROCHLORIDE Recall D-1093-2022

Description: Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-1101-01

PRAZOSIN HYDROCHLORIDE Recall D-1093-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1093-2022
Event ID89646
BrandPRAZOSIN HYDROCHLORIDE
Generic NamePRAZOSIN HYDROCHLORIDE
ManufacturerPRAZOSIN HYDROCHLORIDE
Original Package?1
Active SubstancePRAZOSIN HYDROCHLORIDE
Drug RouteORAL
DistributionUSA nationwide.
Quantity8 bottles/100 tablets each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0378-1101 0378-2302 0378-3205
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 IdentifierX0Z7454B90
Drug Application NumberANDA072575
Structured Product Labeling (SPL ID)376d081e-5363-4c60-8d5a-f1d95cd3c41b
Structured Product Labeling (SPL Set ID)1ce90aaf-d075-4617-9a47-e8d922096d23
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.