FDA Drug recall D-0575-2023
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A San…
- FDA Drug
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A San… by Sanofi Aventis U S, citing lack of Assurance of Sterility: Malformed crimped collar seal.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0575-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-11 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sanofi Aventis U S |
| Distribution | US |
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
Lack of Assurance of Sterility: Malformed crimped collar seal
Identifiers
| ndc | 0024-5924-10 |
|---|---|
| ndc | 0024-5925-01 |
| ndc | 0024-5925-05 |
| ndc | 0024-5925-00 |
| ndc | 0024-5926-05 |
| code_info | Lot # 3F497B, EXP 12-31-2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Sanofi Aventis U S
- Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
FDA Drug · Class II · 2020-08-26 · Sanofi Aventis U S - Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 3740…
FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S - Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0…
FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S - Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S - Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
All Sanofi Aventis U S recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0575-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.