ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufac
Accord Healthcare, Inc. has initiated a Class II recall for Levothyroxine Sodium Tablets, USP, 25 mcg (1000-count bottles) due to the drug being subpotent. The recall is currently classified as ongoing.
This recall affects Accord Healthcare, Inc., its manufacturing partner Intas Pharmaceuticals Limited, and downstream distributors or pharmacies holding the 1000-count bottles of the 25 mcg strength (NDC 16729-447-17).
A subpotency finding suggests potential issues in the manufacturing process, stability profile, or active pharmaceutical ingredient (API) handling. For thyroid hormone replacement therapies, which often have a narrow therapeutic index, subpotency can lead to clinical insufficiency, potentially necessitating increased pharmacovigilance monitoring for therapeutic failure reports.
Quality units should verify inventory for the affected NDC and initiate quarantine procedures for the specified lot. Review stability data and manufacturing controls related to potency to identify the root cause of the subpotency finding.
Class II. Reason: Subpotent Drug. Product: Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.. Firm: ACCORD HEALTHCARE, INC. (Raleigh NC United States). Status: Ongoing.
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