Drug product

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.

D-0003-2026

September 22, 2025

Class II

Product summary

Firm: RC Outsourcing, LLC
Event: Event 97653
Status: Terminated
Classification: Class II
Quantity: 2,669 syringes
Official record key: drug-enforcement:D-0003-2026

Official wording

Reason: Lack of assurance of sterility.

Code information: Lot # 20250708-768A26, BUD: Oct 06, 2025 20250715-944DF2 BUD: Oct 13, 2025 20250722-55C603 BUD: Oct 20, 2025 20250722-5DC113 BUD: Oct 20, 2025

Distribution pattern: Nationwide in the US

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of assurance of sterility