Recalls / Class I
Class ID-0462-2022
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
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.
- Affected lot / code info
- Batch # BF20003118, Exp. August 2022
Why it was recalled
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3711 Collins Ferry Rd, N/A, Morgantown, West Virginia 26505-2362
Distribution
- Quantity
- 73,175 prefilled pens
- Distribution pattern
- Nationwide in the USA and Thailand.
Timeline
- Recall initiated
- 2022-01-05
- FDA classified
- 2022-01-28
- Posted by FDA
- 2022-01-26
- Terminated
- 2024-01-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0462-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.