Recalls / Class II
Class IID-0925-2018
Product
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00
- Brand name
- Admelog
- Generic name
- Insulin Lispro
- Active ingredient
- Insulin Lispro
- Route
- Intravenous, Subcutaneous
- NDCs
- 0024-5924, 0024-5925, 0024-5926
- FDA application
- BLA209196
- Affected lot / code info
- Lot #: 7F021B, Exp 6/30/20
Why it was recalled
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 3214 prefilled pens
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-07-05
- FDA classified
- 2018-07-16
- Posted by FDA
- 2018-07-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0925-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.