Agency classClass IOur severity:Critical FDA (Drugs)·D-0845-2022·Announced 2022-05-04

Insulin Glargine Injection Vials Recalled Due to Missing Labels

Mylan Pharmaceuticals is recalling 89,665 vials of Insulin Glargine Injection (100 units/mL) due to missing labels on the vials. Affected patients should not use the product and should contact their healthcare provider.

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: FDA Class I designation by the FDA indicates a recall of products posing serious hazard with potential for serious adverse consequences. The rubric criteria for Score 5 specifically includes FDA Class I recalls, and a missing label on an insulin vial meets this standard.

Plain-English summary

Mylan Pharmaceuticals Inc is recalling Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in 10 mL multiple-dose vials. The recall involves 89,665 vials with Lot number BF21002800, which have an expiration date of August 2023. Distribution was nationwide throughout the United States.

The recall was initiated due to missing labels on the vials. A missing label on an insulin vial poses a significant safety risk by preventing patients and healthcare providers from verifying critical information such as medication name, concentration, expiration date, lot number, storage instructions, and manufacturer details.

Patients using insulin from the affected lot should discontinue use and contact their healthcare provider or pharmacy immediately to obtain a properly labeled replacement. Healthcare providers and pharmacists should identify and quarantine any Insulin Glargine vials from Lot BF21002800 and notify affected patients to ensure continuity of care.

The recalled product

Product: 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…
Manufacturer: Mylan Pharmaceuticals Inc
Category: Drug — Insulin / Diabetes Medication
Hazard: missing-label
medication-error
Affected units: 89,665

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 #: BF21002800
Exp 8/2023

Distribution

Distributed nationwide across the United States.

Same manufacturer · Mylan Pharmaceuticals Inc

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