Product Safety Recalls

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PANTOPRAZOLE SODIUM Recall D-1104-2022

Description: Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95

PANTOPRAZOLE SODIUM Recall D-1104-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1104-2022
Event ID89646
BrandPANTOPRAZOLE SODIUM
Generic NamePANTOPRAZOLE SODIUM
ManufacturerPANTOPRAZOLE SODIUM
Original Package?1
Active SubstancePANTOPRAZOLE SODIUM
Drug RouteINTRAVENOUS
DistributionUSA nationwide.
Quantity1 carton/10 vials
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0781-3232
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 Identifier6871619Q5X
Drug Application NumberANDA090296
Structured Product Labeling (SPL ID)07ae0485-8a7d-4bda-830c-a2e47c72490f
Structured Product Labeling (SPL Set ID)27c6ccc3-1041-402e-b3bc-fc779a27d584
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