Ajanta Pharma USA Inc — Class II: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Li
Ajanta Pharma USA Inc has initiated a Class II recall for Fenofibrate Capsules, USP 200 mg (100-count bottles) due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured by Ajanta Pharma Limited in India and distributed under NDC 27241-120-04.
Ajanta Pharma USA Inc, healthcare providers dispensing this medication, and quality/compliance departments responsible for monitoring CGMP adherence in contract manufacturing.
A Class II designation suggests that exposure to the product may cause temporary or medically reversible adverse health consequences, though the probability of serious harm is remote. The citation of CGMP deviations indicates a potential failure in the manufacturing process or quality control systems, which may require a review of site-specific production standards or oversight of international manufacturing facilities.
Conduct an immediate inventory reconciliation of the affected NDC and lot numbers if available. Review internal CGMP audit protocols to ensure manufacturing processes at CMOs or international sites align with USP standards to prevent similar deviations.
Class II. Reason: CGMP Deviations. Product: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.. Firm: Ajanta Pharma USA Inc (Bridgewater NJ United States). Status: Ongoing.
Open in openFDA / FDA.gov