Sunny Pharmtech Inc. — Class I: Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactu
Sunny Pharmtech Inc. has initiated a Class I recall for Cyclophosphamide for Injection, USP (1 gram/vial) due to the presence of particulate matter identified as stainless steel. The affected product was manufactured in Taiwan for Long Grove Pharmaceuticals, LLC.
This recall affects Sunny Pharmtech Inc., Long Grove Pharmaceuticals, LLC, oncology treatment facilities, and quality/manufacturing teams involved in the production and distribution of sterile injectable drug products.
The classification as Class I indicates that the FDA believes there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of metallic particulate matter in an injectable product suggests potential failures in the manufacturing process, equipment integrity, or final container closure inspection. Regulatory teams should anticipate heightened scrutiny regarding manufacturing controls and foreign matter detection for the facility involved.
Quality units should review batch records for recent fills of this NDC and evaluate the effectiveness of visual inspection protocols and equipment maintenance schedules for potential metal fatigue or shedding. Regulatory teams must monitor the ongoing status of the recall to ensure all distribution sites have been notified and recovery protocols are executed.
Class I. Reason: Presence of Particulate Matter; identified as stainless steel. Product: 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. Firm: Sunny Pharmtech Inc. (Taoyuan City Taiwan). Status: Ongoing.
Open in openFDA / FDA.gov