Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 m
Summary
The FDA issued a Class I for Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen ( by Mylan Pharmaceuticals Inc. Reason: Labeling: Missing Label: label missing from some Semglee prefilled pens..
Details
Source
Drug Recall
External ID
D-0462-2022
Action Date
2022-01-26
Status
Terminated
Category
drug
Product Description
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
Lot/Code Info: Batch # BF20003118, Exp. August 2022
Quantity Affected: 73,175 prefilled pens
Reason for Recall
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Distribution
Nationwide in the USA and Thailand.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-05
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 44 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-0462-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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