FDA Recall D-0575-2023
Sanofi-Aventis U.S. LLC · Bridgewater, NJ
Class II Ongoing 1129 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
Reason for recall
Lack of Assurance of Sterility: Malformed crimped collar seal
Recall record
- Recall number
D-0575-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-04-11
- Classified by FDA Center
- 2023-05-15
- FDA published
- 2023-05-24
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Firm location
- Bridgewater, NJ
Drug identification
- Brand name(s)
- ADMELOG
- Generic name(s)
- INSULIN LISPRO
- Manufacturer(s)
- Sanofi-Aventis U.S. LLC
- NDC(s)
0024-5924, 0024-5925, 0024-5926- Route(s)
- INTRAVENOUS, SUBCUTANEOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.