Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD54516_1, EXP: 5/20/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W002920, EXP: 6/10/2014.
NIACIN, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904227260.
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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