ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufa
Accord Healthcare, Inc. has initiated a Class II recall for Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) in 1000-count bottles due to the product being subpotent. The product was manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc. and is identified by NDC 16729-453-17.
This recall affects Accord Healthcare, Inc., Intas Pharmaceuticals Limited, and pharmacy/healthcare providers managing 1000-count bulk bottle inventories of levothyroxine sodium.
A Class II recall for subpotency suggests that while the health consequences may be temporary or medically reversible, the product fails to meet its labeled USP specifications for strength. This indicates potential issues in the manufacturing process or stability profile at the Dehradun facility, which may necessitate a review of batch records and quality control oversight for finished dose hormonal therapies.
QA and supply chain teams should immediately verify if NDC 16729-453-17 is in inventory and initiate quarantine procedures according to internal recall protocols. Manufacturing and analytical teams should investigate the root cause of the subpotency, focusing on stability data and manufacturing process controls at the India-based facility.
Class II. Reason: Subpotent Drug. Product: Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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 16729-453-17.. Firm: ACCORD HEALTHCARE, INC. (Raleigh NC United States). Status: Ongoing.
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