Recalls / Class I
Class ID-1292-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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 Specialty L.P., Morgantown, WV
- Affected lot / code info
- Lot #: BF21002895, Exp. Date Aug 2023
Why it was recalled
Labeling: Missing label: Label missing from some prefilled pens.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 5005 Greenbag Rd, Morgantown, West Virginia 26501-7124
Distribution
- Quantity
- 253,200 pens (50,650/5 per packs)
- Distribution pattern
- Product was distributed nationwide within the United States
Timeline
- Recall initiated
- 2022-07-05
- FDA classified
- 2022-07-26
- Posted by FDA
- 2022-08-03
- Terminated
- 2024-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1292-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.