FDAClass IMay 4, 2022

Insulin Glargine recall: Labeling Error

Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80

Why was Insulin Glargine recalled?

Labeling: Missing label on the vial

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: BF21002800, Exp 8/2023

Product
Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80
Recalling firm
Mylan Pharmaceuticals Inc
Quantity
89,665 vials
Distribution
USA nationwide.
Recall date
May 4, 2022
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls