Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: W003477, EXP: 6/20/2014.
NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at…
Reason Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Lack of Processing Controls.
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