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LABETALOL HYDROCHLORIDE Recall D-1094-2022

Description: Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01

LABETALOL HYDROCHLORIDE Recall D-1094-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1094-2022
Event ID89646
BrandLABETALOL HCL
Generic NameLABETALOL HYDROCHLORIDE
ManufacturerLABETALOL HYDROCHLORIDE
Original Package?1
Active SubstanceLABETALOL HYDROCHLORIDE
Drug RouteORAL
DistributionUSA nationwide.
Quantity1 bottle/100 tablets
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC49884-122 49884-123 49884-124
Drug UPC0349884122058 0349884123055 0349884124052
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 Identifier1GEV3BAW9J
Drug Application NumberANDA200908
Structured Product Labeling (SPL ID)c2fd5bf2-ce6b-48a7-a782-17dd1df2d326
Structured Product Labeling (SPL Set ID)56ab2ff4-14a6-4297-afd8-56b92e1f64a0
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