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Lack of Assurance of Sterility
Presence of Particulate Matter: identified as glass.
This recall involves Solaray Liposomal Women's in 60 and 120 count, Solaray Universal Multivitamin in 60 and 120 count, and Solaray Liposomal Women's 50+ Multivitamin in 120 count. The bottles are a clear silver color with white pop top lids. The white label on the front of the bottles displays the Solaray logo, product name, product type and size count. The 60 count bottles are contained in cartons, which are substantially similar in appearance to the bottles inside. All lots are included in the recall. Name Count SKU Solaray Liposomal Women's 60 076280193251 Solaray Liposomal Women's 120 076280339536 Solaray Universal Multivitamin 60 076280640168 Solaray Universal Multivitamin 120 076280830385 Solaray Liposomal Women's 50+ Multivitamin 120 076280154832
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.