Product Safety Recalls

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DOXYCYCLINE Recall D-1032-2022

Description: Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50

DOXYCYCLINE Recall D-1032-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1032-2022
Event ID89646
BrandDOXYCYCLINE
Generic NameDOXYCYCLINE
ManufacturerDOXYCYCLINE
Original Package?1
Active SubstanceDOXYCYCLINE
Drug RouteORAL
DistributionUSA nationwide.
Quantity3 bottles
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC63304-614 63304-615 63304-616
Product NUIN0000175882 N0000007948
Drug UPC0363304614015
Pharma Class (EPC)Tetracycline-class Drug [EPC]
Pharma Class (CS)Tetracyclines [Chemical/Ingredient]
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 IdentifierN12000U13O
Drug Application NumberANDA065053
Structured Product Labeling (SPL ID)d87fed49-4d26-4c1e-a097-7922f0f4d967
Structured Product Labeling (SPL Set ID)829dbd3d-5c2b-47b8-96a5-423af78c93b9
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