17 recalls · Class II, newest first
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
CGMP Deviations and Presence of Particulate Matter: Glass
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Presence of Foreign Tablets/Capsules
GMP Deviations: A silicone particulate was noted in Ozurdex.
Presence of Foreign Substance: foreign material found in the bulk inventory.