Class I
Terminated
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.
This recall has been terminated (originally issued January 26, 2022).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- January 5, 2022
- Posted
- January 26, 2022
- Recall Number
- D-0462-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 73,175 prefilled pens
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Distribution
Nationwide in the USA and Thailand.
Lot / Code Info
Batch # BF20003118, Exp. August 2022
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