Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; traMADol HCl Tablet, 25 mg (1/2 of 50 mg) may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00527163801, Pedigree: AD60272_76, EXP: 5/22/2014.
traMADol HCl Tablet, 25 mg (1/2 of 50 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664037708
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 Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability…
Reason Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count…
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Reason Packaging defect: blister packaging inadequately sealed.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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