Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside
Summary
The FDA issued a Class I for Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packag by Mylan Pharmaceuticals Inc. Reason: Labeling: Missing label on the vial.
Details
Source
Drug Recall
External ID
D-0845-2022
Action Date
2022-05-04
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: BF21002800, Exp 8/2023
Quantity Affected: 89,665 vials
Reason for Recall
Labeling: Missing label on the vial
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-12
Company
Morgantown, WV
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 121 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Mylan Pharmaceuticals Inc has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mylan Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mylan Pharmaceuticals Inc have FDA actions?
Mylan Pharmaceuticals Inc has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0845-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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