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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
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
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.
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Failed Impurities/Degradation Specifications
Lack of Assurance of Sterility
potential contamination with E coli
potential contamination with E coli
Lack of Assurance of Sterility
Lack of Assurance of Sterility