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
Reported: August 3, 2022 Initiated: July 5, 2022 #D-1292-2022
Product Description
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
Reason for Recall
Labeling: Missing label: Label missing from some prefilled pens.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc
- Units Affected
- 253,200 pens (50,650/5 per packs)
- Distribution
- Product was distributed nationwide within the United States
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Pharmaceuticals Inc. Units affected: 253,200 pens (50,650/5 per packs).
Why was this product recalled? ▼
Labeling: Missing label: Label missing from some prefilled pens.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 3, 2022. Severity: Critical. Recall number: D-1292-2022.
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