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
Reported: May 24, 2023 Initiated: April 11, 2023 #D-0575-2023
Product Description
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
Details
- Recalling Firm
- Sanofi-Aventis U.S. LLC
- Units Affected
- 51,325 vials
- Distribution
- Nationwide in the USA
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sanofi-Aventis U.S. LLC. Units affected: 51,325 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Malformed crimped collar seal
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 24, 2023. Severity: Moderate. Recall number: D-0575-2023.
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