VITRUVIAS THERAPEUTICS INC — Class I: Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg,
Vitruvias Therapeutics Inc. has initiated a Class I recall for Thyroid Tablets, USP, 1/2 Grain (30 mg) due to the product being identified as a superpotent drug. The affected product contains levothyroxine (T4) and liothyronine (T3) and is distributed under NDC 69680-166-00.
This recall affects Vitruvias Therapeutics Inc., distributors, pharmacies, and healthcare providers involved in the supply chain of thyroid hormone replacement therapies, as well as internal Quality and Compliance departments.
A Class I designation is the FDA's most serious recall category, indicating that exposure to the violative product could cause serious adverse health consequences or death. The identification of the drug as 'superpotent' suggests a significant failure in manufacturing controls or potency testing, which may trigger increased regulatory scrutiny of the firm's quality management systems and active pharmaceutical ingredient (API) sourcing.
QA and Manufacturing teams should immediately review potency testing protocols and batch records for thyroid-based products. Regulatory teams must ensure that recall communications effectively reach the end-user level due to the Class I designation. Investigating the root cause of the superpotency—whether related to raw material variability or formulation errors—is essential for CAPA documentation.
Class I. Reason: Superpotent Drug. Product: Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Product of USA, NDC 69680-166-00.. Firm: VITRUVIAS THERAPEUTICS INC (Auburn AL United States). Status: Ongoing.
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