D-0462-2022 Class I Terminated
FDA drug recall D-0462-2022 was initiated by Mylan Pharmaceuticals Inc on Jan 5, 2022 and is designated Class I. Reason for recall: Labeling: Missing Label: label missing from some Semglee prefilled pens. The recall status is terminated (terminated Jan 12, 2024). Affected quantity: 73,175 prefilled pens.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 26, 2022
- Initiation Date
- Jan 5, 2022
- Termination Date
- Jan 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73,175 prefilled pens
Product description
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.
Reason for recall
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Distribution pattern
Nationwide in the USA and Thailand.
Code information
Batch # BF20003118, Exp. August 2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0462-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026