Why it was recalled
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 7F021B, Exp 6/30/20
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0925-2018
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 5, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 3214 prefilled pens
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanofi-Aventis U.S. LLC
Original FDA data
Every field from FDA enforcement report D-0925-2018, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 80387
- Address
- 55 Corporate Dr
- Code information
- Lot #: 7F021B, Exp 6/30/20
- Postal code
- 08807-1265
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0925-2018
- Classification
- Class II
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Product quantity
- 3214 prefilled pens
- Reason for recall
- Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2018