PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: May 4, 2022 Initiated: April 12, 2022 #D-0845-2022

Product Description

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

Reason for Recall

Labeling: Missing label on the vial

Details

Recalling Firm
Mylan Pharmaceuticals Inc
Units Affected
89,665 vials
Distribution
USA nationwide.
Location
Morgantown, WV

Frequently Asked Questions

What product was recalled?
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. Recalled by Mylan Pharmaceuticals Inc. Units affected: 89,665 vials.
Why was this product recalled?
Labeling: Missing label on the vial
Which agency issued this recall?
This recall was issued by the FDA Drug on May 4, 2022. Severity: Critical. Recall number: D-0845-2022.