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LOPERAMIDE HYDROCHLORIDE Recall D-1092-2022

Description: Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-2100-01

LOPERAMIDE HYDROCHLORIDE Recall D-1092-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1092-2022
Event ID89646
BrandLOPERAMIDE HYDROCHLORIDE
Generic NameLOPERAMIDE HYDROCHLORIDE
ManufacturerLOPERAMIDE HYDROCHLORIDE
Original Package?1
Active SubstanceLOPERAMIDE HYDROCHLORIDE
Drug RouteORAL
DistributionUSA nationwide.
Quantity1 bottle/100 capsules
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0378-2100
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 Identifier77TI35393C
Drug Application NumberANDA072741
Structured Product Labeling (SPL ID)bdc33c76-c301-4772-9c97-c654acd538c1
Structured Product Labeling (SPL Set ID)72a7ae47-cdf3-4949-b9f8-f29b153f787f
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