D-0925-2018 Class II Ongoing
FDA drug recall D-0925-2018 was initiated by Sanofi-Aventis U.S. LLC on July 5, 2018 and is designated Class II. Reason for recall: Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. The recall status is ongoing. Affected quantity: 3214 prefilled pens.
Recall Details
- Product Type
- Drugs
- Report Date
- July 18, 2018
- Initiation Date
- July 5, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3214 prefilled pens
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
Reason for Recall
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Distribution Pattern
Nationwide
Code Information
Lot #: 7F021B, Exp 6/30/20