Insulin Glargine Prefilled Pens Recalled for Missing Label
Mylan Pharmaceuticals is recalling Insulin Glargine prefilled pens (lot BF21002895) distributed nationwide because some pens lack labels, which could prevent patients from properly identifying and administering the medication.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which is classified as Critical per the severity rubric criteria. FDA Class I recalls are the most serious designation, indicating a condition with the potential to cause serious adverse health consequences or death.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), supplied in 3 mL prefilled pens. The recalled product is lot BF21002895 with an expiration date of August 2023. Approximately 253,200 pens were distributed nationwide within the United States.
Some of the prefilled pens are missing their labels. The missing label could prevent patients from properly identifying the medication and could contribute to medication errors or incorrect administration.
Patients who have received affected pens should check their insulin pens immediately for the presence of a label. Any person with a pen that lacks a label should not use the medication and should contact their healthcare provider or pharmacist before attempting any injection.
Healthcare providers and patients with questions should contact Mylan Pharmaceuticals Inc. for more information about this recall.
The recalled product
- Product
- Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan…
- Manufacturer
- Mylan Pharmaceuticals Inc
- Category
- Drug — Insulin Injection
- Hazard
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)
- Lot #: BF21002895
- Exp. Date Aug 2023
Distribution
Distributed nationwide across the United States.
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