Drug Enforcement D-0646-2025

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

September 24, 2025

Termination Date

—

Product Information

Product description
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Product quantity
109,320 syringes
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

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

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

Codes & Dates

Recall number
D-0646-2025
Event ID
97540
Recall initiation date
August 29, 2025
Center classification date
September 12, 2025
Code info
Lot #: C274-000044756, C274-000044757, Exp 8-30-2025; C274-000044832, C274-000044833, Exp 9-4-2025; C274-000044882, C274-000044883, Exp 9-6-2025, C274-000044972, Exp 9-8-2025; C274-000045004, C274-000045005, Exp 9-18-2025 C274-000045108, exp. date 9-13-2025 C274-000045109, exp. date 9-13-2025 C274-000045136, exp. date 9-14-2025 C274-000045137, exp. date 9-14-2025 C274-000045289, exp. date 9-20-2025 C274-000045290, exp. date 9-20-2025 C274-000045350, exp. date 9-22-2025 C274-000045351, exp. date 9-22-2025 C274-000045387, exp. date 9-25-2025 C274-000045388, exp. date 9-25-2025 C274-000045516, exp. date 9-27-2025 C274-000045517, exp. date 9-27-2025 C274-000045586, exp. date 10-2-2025 C274-000045587, exp. date 10-2-2025 C274-000045676, exp. date 10-4-2025 C274-000045677, exp. date 10-4-2025 C274-000045707, exp. date 10-5-2025 C274-000045708, exp. date 10-5-2025 C274-000045754, exp. date 10-9-2025 C274-000045755, exp. date 10-9-2025 C274-000045840, exp. date 10-11-2025 C274-000045841, exp. date 10-11-2025 C274-000046048, exp. date 10-24-2025 C274-000046049, exp. date 10-24-2025 C274-000046095, exp. date 10-25-2025 C274-000046096, exp. date 10-25-2025 C274-000046122, exp. date 10-26-2025 C274-000046123, exp. date 10-26-2025 C274-000046164, exp. date 10-30-2025 C274-000046165, exp. date 10-30-2025 C274-000046191, exp. date 10-31-2025 C274-000046192, exp. date 10-31-2025 C274-000046240, exp. date 11-1-2025 C274-000046241, exp. date 11-1-2025 C274-000046315, exp. date 11-6-2025 C274-000046316, exp. date 11-6-2025 C274-000046345, exp. date 11-7-2025 C274-000046346, exp. date 11-7-2025 C274-000046515, exp. date 11-14-2025 C274-000046516, exp. date 11-14-2025 C274-000046603, exp. date 11-16-2025 C274-000046657, exp. date 11-20-2025 C274-000047136, exp. date 12-12-2025
More code info
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