Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434
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 Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
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