Semglee Insulin Glargine Prefilled Pens Missing Label
Mylan Pharmaceuticals is recalling approximately 73,175 Semglee (insulin glargine) prefilled pens nationwide because some units have a missing label. Patients should check their pens and contact their pharmacist or doctor if affected.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall involving a critical-use medication (insulin) where missing labeling could directly lead to medication errors or improper administration. Although no illnesses have been reported, the hazard involves a prescription drug essential for managing diabetes, and the Class I classification by FDA requires a minimum score of 4 per the rubric.
Plain-English summary
Mylan Pharmaceuticals Inc is recalling Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71 and packaged in Five 3 mL Prefilled Pens per carton, NDC 49502-0196-75) because some prefilled pens are missing their label. Batch # BF20003118 with expiration date August 2022 is affected.
Approximately 73,175 prefilled pens were distributed nationwide in the USA and Thailand. The missing label creates a risk of medication error or confusion regarding proper use of this prescription insulin product.
Patients and healthcare providers should inspect their Semglee pens to verify the label is present. Anyone who has received an affected pen should contact their pharmacist or healthcare provider immediately for guidance.
The recalled product
- Product
- 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.
- Manufacturer
- Mylan Pharmaceuticals Inc
- Affected units
- 73,175
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # BF20003118
- Exp. August 2022
Distribution
Distributed nationwide across the United States.
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