Major Pharmaceuticals — Class II: Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blis
Major Pharmaceuticals has initiated a Class II recall for Levothyroxine Sodium Tablets, USP, 150 mcg, packaged in 10-count unit dose blisters, due to the product being identified as a subpotent drug.
This affects Major Pharmaceuticals, Cardinal Health, and healthcare facilities or pharmacies utilizing unit-dose Levothyroxine Sodium tablets from the specified NDC batches.
A subpotency finding suggests potential issues in manufacturing consistency, stability, or raw material quality. For a narrow therapeutic index drug like levothyroxine, subpotency may lead to inconsistent clinical outcomes, likely necessitating a review of batch release data and stability monitoring for related product lines.
QA and Supply Chain teams should immediately identify and sequester affected NDC lots (55154-3563-0; 0904-6956-61). Regulatory and manufacturing teams should evaluate stability testing protocols and potency assay validation to mitigate future subpotency risks.
Class II. Reason: Subpotent Drug. Product: Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 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: 55154-3563-0; NDC Blister: 0904-6956-61. Firm: Major Pharmaceuticals (Dublin OH United States). Status: Ongoing.
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