All recalls8,436 total
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Product contains higher sodium amount than stated on label
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.
Presence of Foreign Tablets/Capsules.
Failed Dissolution Specifications - low dissolution results
Presence of foreign tablets/capsules
Chemical Contamination: Presence of benzene.
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Undeclared soy lecithin and undeclared color additives Blue 1 Lake, Yellow 6, Red 40, Yellow 5, Blue 1, Yellow 6 Lake, Red 40 Lake, Yellow 5 Lake, Blue 2 Lake, Blue 2.
Potential contamination with Listeria monocytogenes.
Potential foreign material (stainless steel wire)
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
The firm received complaints of spoilage and illness with the use of the products.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
The firm received complaints of spoilage and illness with the use of the products.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Presence of Particulate Matter
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Contains undeclared colors (FD&C Blue 1 and FD&C Red 40)
Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label.
Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label.
Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label.
Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label.
Elevated levels of Sulfites in Dried Longan Pulp
Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label.
Various non-shelf stable packaged vegetables missing "Keep Refrigerated" statement on label.
Lack of Assurance of Sterility: due to a quality control process deviation
Undeclared Allergen (Milk)
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.
Product lacks 510(k) clearance.