ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC
Accord Healthcare, Inc. has initiated a Class II recall for Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), due to reports of the product being subpotent. The recall involves 90-count and 1000-count bottles manufactured by Intas Pharmaceuticals Limited.
This recall affects Accord Healthcare, Inc., Intas Pharmaceuticals Limited, and pharmacy practitioners or distributors holding the specific NDC lots of Levothyroxine Sodium 200 mcg tablets.
A Class II recall for subpotency in a narrow therapeutic index drug like levothyroxine is significant, as even minor deviations in active ingredient concentration can impact clinical efficacy. This suggests potential issues in manufacturing consistency, stability, or active pharmaceutical ingredient (API) degradation that may require a review of production controls and stability monitoring.
QA and Manufacturing teams should verify current stability data for levothyroxine batches and ensure that potency testing protocols are robust enough to detect subpotency throughout the product lifecycle. Distribution departments must facilitate the removal of affected 90-count and 1000-count bottles from the supply chain.
Class II. Reason: Subpotent Drug. Product: Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), 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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