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.
Reported: January 26, 2022 Initiated: January 5, 2022 #D-0462-2022
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc
- Units Affected
- 73,175 prefilled pens
- Distribution
- Nationwide in the USA and Thailand.
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Pharmaceuticals Inc. Units affected: 73,175 prefilled pens.
Why was this product recalled? ▼
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 26, 2022. Severity: Critical. Recall number: D-0462-2022.
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