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NALTREXONE HYDROCHLORIDE Recall D-1039-2022

Description: Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03

NALTREXONE HYDROCHLORIDE Recall D-1039-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1039-2022
Event ID89646
BrandNALTREXONE HYDROCHLORIDE
Generic NameNALTREXONE HYDROCHLORIDE
ManufacturerNALTREXONE HYDROCHLORIDE
Original Package?1
Active SubstanceNALTREXONE HYDROCHLORIDE
Drug RouteORAL
DistributionUSA nationwide.
Quantity4 bottles/30 tablets per bottle
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0406-1170
Drug UPC0304061170017
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 IdentifierZ6375YW9SF
Drug Application NumberANDA076264
Structured Product Labeling (SPL ID)f7ac0547-6c8d-4a03-91f4-2c37215554ae
Structured Product Labeling (SPL Set ID)06ff2d5a-e62b-4fa4-bbdb-01938535bc65
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