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Products contain undeclared soy protein isolate.
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
An ingredient used in the manufacture of finished product was discovered to have been grown using unapproved herbicide.
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
In House testing found a residue of 0.927 ppm of Zeta-cypermethrin on raspberries, which is above the U.S. MRL of 0.800 ppm
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
The firm was notified by their customer that the product contains Chicken Nuggets instead of Fish Nuggets
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Canisters containing Iodized Salt are labeled with Plain Salt labels, causing dextrose and potassium iodide to be undeclared ingredients.
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Lack of Assurance of Sterility
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Product is recalled due to the potential presence of glyphosate.
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.