Sunny Pharmtech Inc. — Class I: Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactu
Sunny Pharmtech Inc. has initiated a Class I recall for Cyclophosphamide for Injection, USP (2 gram/vial) due to the presence of stainless steel particulate matter. The recall remains ongoing and involves single-dose vials manufactured for Long Grove Pharmaceuticals, LLC.
This recall affects Sunny Pharmtech Inc., Long Grove Pharmaceuticals, LLC, and healthcare facilities or clinical sites managing oncology drug supplies involving NDC 81298-8114-1.
A Class I designation indicates the FDA's assessment of a high risk for serious adverse health consequences or death. The presence of metallic particulate matter in an injectable product suggests potential failures in manufacturing controls or equipment integrity. This may lead to increased regulatory scrutiny of the manufacturer's Taoyuan City facility and its quality management systems.
Quality teams should review visual inspection protocols for injectable products and verify supplier oversight for contract manufacturing sites in Taiwan. Facilities using similar fill-finish equipment should assess the risk of stainless steel shedding during the manufacturing process.
Class I. Reason: Presence of Particulate Matter; identified as stainless steel. 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. Firm: Sunny Pharmtech Inc. (Taoyuan City Taiwan). Status: Ongoing.
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