FDA DrugClass IINotable
FDA Recall: Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett C
Description
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Hazard
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Remedy
3984 bottles
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