Drug Enforcement D-0636-2024

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

August 28, 2024

Termination Date

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Product Information

Product description
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
Product quantity
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Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Fagron Compounding Services
Address
8710 E 34th St N

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

Codes & Dates

Recall number
D-0636-2024
Event ID
95146
Recall initiation date
August 15, 2024
Center classification date
August 16, 2024
Code info
Lot#: C274-000037397, C274-000037398, C274-000037399, C274-000037400, Exp. Date 10/14/2024.
More code info
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