Major Pharmaceuticals — Class II: Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blist
Major Pharmaceuticals has initiated a Class II recall for Levothyroxine Sodium Tablets, USP, 88 mcg (NDC 0904-6952-61) due to the product being identified as a subpotent drug. The recall involves unit dose blisters (10 x 10) and is currently classified as an ongoing enforcement action.
This recall affects Major Pharmaceuticals, healthcare providers, pharmacists, and supply chain managers handling the specified 88 mcg levothyroxine sodium unit dose blisters.
A Class II recall for a subpotent drug suggests a quality control failure that could lead to temporary or reversible adverse health consequences. For narrow therapeutic index drugs like levothyroxine, potency deviations are particularly significant as they may result in inadequate thyroid hormone replacement. Regulatory teams should view this as a signal to audit manufacturing or repackaging specifications for potency consistency.
Quality and supply chain teams should immediately identify and sequester NDC 0904-6952-61 from inventory. Regulatory and QA departments should review stability data and manufacturing controls for levothyroxine products to ensure potency standards are maintained throughout the labeled shelf life.
Class II. Reason: Subpotent Drug. Product: Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61. Firm: Major Pharmaceuticals (Dublin OH United States). Status: Ongoing.
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