Product Safety Recalls

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AMPICILLIN SODIUM Recall D-1009-2022

Description: Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10

AMPICILLIN SODIUM Recall D-1009-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1009-2022
Event ID89646
BrandAMPICILLIN
Generic NameAMPICILLIN SODIUM
ManufacturerAMPICILLIN SODIUM
Original Package?1
Active SubstanceAMPICILLIN SODIUM
Drug RouteINTRAMUSCULAR
DistributionUSA nationwide.
Quantity10 cartons/10 vials each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC55150-111 55150-112 55150-113
Drug UPC0355150112104 0355150113101 0355150111107
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 IdentifierJFN36L5S8K
Drug Application NumberANDA065499
Structured Product Labeling (SPL ID)768505cc-508a-40e1-a6d8-eacf9d60b907
Structured Product Labeling (SPL Set ID)b7bf2897-8272-4c7d-84e9-6fbba0ea63fa
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