Major Pharmaceuticals — Class II: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose bliste
Major Pharmaceuticals has initiated a Class II recall for Levothyroxine Sodium Tablets (75 mcg) in unit dose blister packs due to reports of the drug being subpotent. The product was packaged and distributed by Major Pharmaceuticals and further distributed by Cardinal Health.
This recall affects Major Pharmaceuticals, Cardinal Health, and pharmaceutical distributors and pharmacies handling NDC 55154-3560-0 and NDC 0904-6951-61. Quality and supply chain professionals at these organizations are primary stakeholders.
A Class II recall for subpotency suggests a failure to meet established specifications for active ingredient concentration. For regulatory teams, this indicates a potential issue in the manufacturing, stability, or packaging process that may require investigation into Batch Release records and stability data to ensure continued compliance with USP standards.
Regulatory and Quality teams should verify if any impacted NDC lots remain in the supply chain. QA should evaluate whether current stability testing or storage conditions protocols require adjustment to prevent subpotency issues in similar thyroid hormone products.
Class II. Reason: Subpotent Drug. Product: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61. Firm: Major Pharmaceuticals (Dublin OH United States). Status: Ongoing.
Open in openFDA / FDA.gov