Product Safety Recalls

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HYDROXYZINE PAMOATE Recall D-1046-2022

Description: HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01

HYDROXYZINE PAMOATE Recall D-1046-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1046-2022
Event ID89646
BrandHYDROXYZINE PAMOATE
Generic NameHYDROXYZINE PAMOATE
ManufacturerHYDROXYZINE PAMOATE
Original Package?1
Active SubstanceHYDROXYZINE PAMOATE
Drug RouteORAL
DistributionUSA nationwide.
Quantity30 bottles/100 capsules per bottle
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0185-0615 0185-0674 0185-0613
Drug UPC0301850613014
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 IdentifierM20215MUFR
Drug Application NumberANDA086183
Structured Product Labeling (SPL ID)65bed804-a514-4e9f-87b3-1dd026778a6c
Structured Product Labeling (SPL Set ID)c38cfd32-2562-4d6c-8a2e-d9984c16d9eb
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