Class II · Moderate risk Completed
Sterile Diluent
Reason CGMP Deviations
Insulin Glargine
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Missing label on the vial
What 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
- Recalling firm
- Mylan Pharmaceuticals Inc
- NDC code
- 49502-393-80
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0845-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Insulin recalls
See all
Class II · Moderate risk Ongoing
Admelog
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Class I · High risk Terminated
Insulin Glargine
Reason Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk Completed
Humalog KwikPen
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk Terminated
Semglee
Reason Labeling: Missing Label: label missing from some Semglee prefilled pens.
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