Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002690, EXP: 6/5/2014.
RASAGILINE MESYLATE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68546014256
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 - results obtained were below spec average.
Reason Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
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