ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufact
Accord Healthcare, Inc. has initiated a Class II recall for Levothyroxine Sodium Tablets, USP, 50 mcg (1000-count bottles) due to the product being identified as a subpotent drug. The recall is currently classified as ongoing.
This recall affects Accord Healthcare, Inc., Intas Pharmaceuticals Limited, and pharmacy distributors or healthcare facilities utilizing the 1000-count bulk bottles of 50 mcg Levothyroxine Sodium.
A Class II recall for subpotency suggests a failure to meet USP specifications, which may stem from manufacturing deviations or stability issues. For a narrow therapeutic index drug like levothyroxine, subpotency can lead to clinical under-treatment. Regulatory teams may expect increased scrutiny regarding the manufacturer's stability testing programs and process controls.
Quality units should verify if affected lot numbers of Levothyroxine Sodium (NDC 16729-448-17) are in inventory and initiate quarantine procedures. Regulatory and QA teams should review stability data for similar product lines to ensure continued potency throughout the shelf life.
Class II. Reason: Subpotent Drug. Product: Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 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 16729-448-17.. Firm: ACCORD HEALTHCARE, INC. (Raleigh NC United States). Status: Ongoing.
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