Admelog Injection, Solution
FDA Recall NDC 0024-5926

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Admelog (NDC 0024-5926). A significant event, classified as Class II, was initiated on Apr 11, 2023 by Sanofi-aventis U.s. Llc. The reported reason for this action was: "Lack of Assurance of Sterility: Malformed crimped collar seal"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0575-2023ONGOINGD-0925-2018ONGOING

April 2023 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0575-2023
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility: Malformed crimped collar seal
Initiated
Apr 11, 2023
Reported
May 24, 2023
Quantity
51,325 vials

Recall Profile & Regulatory Data

Event ID
92074
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Sanofi-Aventis U.S. LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# 3F497B, EXP 12-31-2025
Affected Packages Involved in this Recall
0024-5924-10Product
0024-5925-01Product
0024-5925-05Product
0024-5925-00Product
0024-5926-05Product

July 2018 Class II Recall: Temperature Abuse

Recall Number
D-0925-2018
Class II Ongoing
Reason for Recall
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Initiated
Jul 05, 2018
Reported
Jul 18, 2018
Quantity
3214 prefilled pens

Recall Profile & Regulatory Data

Event ID
80387
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Sanofi-Aventis U.S. LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
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
Batch or Lot Expiration Information
Lot# : 7F021B, Exp 6/30/20
Affected Packages Involved in this Recall
0024-5924-10Product
0024-5925-01Product
0024-5925-05Product
0024-5925-00Product
0024-5926-05Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.