Class II recall: ACCORD HEALTHCARE, INC.: Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count b
The FDA has classified as Class II a recall by Accord Healthcare, Inc. of Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), affecting 90-count bottles (NDC 16729-454-15) and 1000-count bottles (NDC 16729-454-17). The product, manufactured by Intas Pharmaceuticals Limited in India, was recalled due to being subpotent, according to the recall notice.
Most relevant for: Children and adults requiring thyroid hormone replacement therapy who may have received subpotent levothyroxine tablets from the affected batches.
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