Drug Enforcement D-0575-2023

Lack of Assurance of Sterility: Malformed crimped collar seal

Status

Ongoing

Classification

Class II

Report Date

May 24, 2023

Termination Date

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Product Information

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
Product quantity
51,325 vials
Reason for recall
Lack of Assurance of Sterility: Malformed crimped collar seal
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Sanofi-Aventis U.S. LLC
Address
55 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0575-2023
Event ID
92074
Recall initiation date
April 11, 2023
Center classification date
May 15, 2023
Code info
Lot # 3F497B, EXP 12-31-2025
More code info
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