Cyclophosphamide Injection Recall: Stainless Steel Particulate Matter Found
Cyclophosphamide for Injection, USP, 2 gram/vial, is being recalled due to the presence of particulate matter identified as stainless steel. The recall affects 1,464 vials distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which the rubric specifies should never be scored below 4 (Severe). The presence of stainless steel particulate matter in a chemotherapy injection poses a direct risk of physical harm if administered to patients.
Plain-English summary
Sunny Pharmtech Inc. is recalling Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, NDC 81298-8114-1, Lot # V24010V1, Exp 3/31/2027, due to the presence of particulate matter identified as stainless steel. The product was manufactured for Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018, and manufactured in Taiwan.
A total of 1,464 vials are included in this recall. The product was distributed nationwide in the USA.
Cyclophosphamide is a chemotherapy medication. The presence of stainless steel particulate matter in the vials poses a potential risk to patients if administered.
Healthcare providers and pharmacies that have the affected lot should stop using or dispensing the product immediately and contact Long Grove Pharmaceuticals, LLC, or Sunny Pharmtech Inc. to arrange for return or disposal of the affected product. Consumers or patients with questions should contact their healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Sunny Pharmtech Inc.
- Category
- Drug — Oncology / Chemotherapy
- Affected units
- 1,464
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # V24010V1
- Exp 3/31/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sunny Pharmtech Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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