Product Safety Recalls

Product Recall Tracker

HYDROCORTISONE Recall D-1045-2022

Description: Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30

HYDROCORTISONE Recall D-1045-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1045-2022
Event ID89646
BrandHYDROCORTISONE
Generic NameHYDROCORTISONE
ManufacturerHYDROCORTISONE
Original Package?1
Active SubstanceHYDROCORTISONE
Drug RouteTOPICAL
DistributionUSA nationwide.
Quantity1 tube
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0168-0080 0168-0146
Product NUIN0000175576 N0000175450
Drug UPC0301680146300 0301680080314
Pharma Class (EPC)Corticosteroid [EPC]
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 IdentifierWI4X0X7BPJ
Drug Application NumberANDA089414
Structured Product Labeling (SPL ID)b70bed43-6eed-4355-90b5-9d0819c13ebd
Structured Product Labeling (SPL Set ID)bcd103f3-3dc8-4394-b8fd-8f8ddb721f77
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