FDA-Drug2026-08-12Class IPROCESSING DEFECT
Sunny Pharmtech Cyclophosphamide for Injection recalled for stainless steel particulate matter
What this means
Cyclophosphamide for Injection USP 2 gram vials manufactured by Sunny Pharmtech (for Long Grove Pharmaceuticals) were found to contain stainless steel particulate matter. The affected lot V24010V1 (expiration 3/31/2027) was distributed nationwide. A total of 1,464 vials are involved in this recall.
- If you have vials from lot V24010V1, do not use them.
- Contact your pharmacy or healthcare provider immediately with the lot number and NDC (81298-8114-1).
- Return unused vials to the manufacturer or pharmacy for proper disposal.
The agency's original wording
Hazard
Presence of Particulate Matter; identified as stainless steel
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
1,464 vials
Manufactured in
Hsinchu Science Park, No. 255 Longyuan 1st Rd.; Longtan Dist., Taoyuan City, Taiwan
Products
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0744-2026More Sunny Pharmtech recalls
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