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Drug Class I · high risk Ongoing

Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1

Presence of Particulate Matter; identified as stainless steel

Recalling firmSunny Pharmtech Inc.
ReasonPresence of Particulate Matter; identified as stainless steel
Risk classClass I (Class I · high risk)
StatusOngoing
Report dateAug 12, 2026
InitiatedJul 17, 2026
RegionTaiwan
DistributionUSA Nationwide
Quantity4,077 vials
Code/LotLot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
TypeVoluntary: Firm initiated
Recall numberD-0743-2026

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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