ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (ND
Accord Healthcare, Inc. has initiated a Class II recall for specific lots of Levothyroxine Sodium Tablets, USP (137 mcg) due to reports of the product being subpotent. The recall includes both 90-count and 1000-count bottles manufactured by Intas Pharmaceuticals Limited.
This recall affects Accord Healthcare, Inc., Intas Pharmaceuticals Limited, and pharmacy distributors or healthcare providers managing inventory for Levothyroxine Sodium Tablets (137 mcg).
A Class II recall for subpotency suggests a failure in maintaining the established specifications for active ingredient concentration, which may stem from stability issues or manufacturing process variations. For regulatory and quality teams, this underscores the necessity of robust potency testing and stability monitoring, as subpotent thyroid medication can lead to inconsistent clinical outcomes for patients.
Quality units should verify inventory against the identified NDC numbers and ensure that subpotent product is quarantined. QA teams should evaluate stability data and manufacturing controls at the site of manufacture to address the root cause of the potency deviation.
Class II. Reason: Subpotent Drug. Product: Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.. Firm: ACCORD HEALTHCARE, INC. (Raleigh NC United States). Status: Ongoing.
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