Lupin Pharmaceuticals Inc. — Class II: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceutic
Lupin Pharmaceuticals Inc. has initiated a Class II recall for Liraglutide Injection (18 mg/3 mL) due to the presence of foreign particulate matter, specifically a white thread-like structure found within the cartridge. The recall is currently marked as ongoing and affects both 2-pen and 3-pen packaging configurations.
This affects Lupin Pharmaceuticals Inc., healthcare providers dispensing Liraglutide, and personnel responsible for injectable drug manufacturing and quality oversight.
The discovery of particulate matter in a sterile injectable cartridge suggests a potential breach in sterile manufacturing or primary packaging integrity. This classification indicates that while the health risk may be temporary or medically reversible, it requires immediate corrective and preventive action (CAPA) to identify the source of the thread-like material, which could be related to garment shedding, filtration failure, or machinery components.
Quality and manufacturing teams should review visual inspection protocols for cartridge-based injectables and verify that particulate matter detection systems are calibrated to identify organic or thread-like contaminants. Distribution teams should monitor inventory for the specific NDCs (70748-346-02 and 70748-346-03) and ensure quarantine evidence is documented.
Class II. Reason: Presence of particulate matter: a white thread-like structure in the cartridge. Product: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.. Firm: Lupin Pharmaceuticals Inc. (Naples FL United States). Status: Ongoing.
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