Product Safety Recalls

Product Recall Tracker

INSULIN GLARGINE Recall D-1292-2022

Description: Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV

INSULIN GLARGINE Recall D-1292-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1292-2022
Event ID90545
BrandINSULIN GLARGINE
Generic NameINSULIN GLARGINE-YFGN
ManufacturerINSULIN GLARGINE-YFGN
Original Package?1
Active SubstanceINSULIN GLARGINE
Drug RouteSUBCUTANEOUS
DistributionProduct was distributed nationwide within the United States
Quantity253,200 pens (50,650/5 per packs)
Recall ReasonLabeling: Missing label: Label missing from some prefilled pens.
Drug ClassificationClass I
Drug Code Info20220803
Product NDC49502-393 49502-394
Product NUIM0011417 N0000175453
Pharma Class (EPC)Insulin Analog [EPC]
Pharma Class (CS)Insulin [CS]
Recall Initiation Date20220705
Report Date20220803
Classification Date20220726
Address5005 Greenbag Rd
Morgantown, WV 26501-7124
United States
Recalling FirmMylan Pharmaceuticals Inc
Initial Notification Press Release
Unique Ingredient Identifier2ZM8CX04RZ
Drug Application NumberBLA761201
Structured Product Labeling (SPL ID)a14de887-e390-4d3f-8863-48ca77969e2e
Structured Product Labeling (SPL Set ID)f8cf3733-952d-4cf1-99ff-5ec7b7247f75
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