11,818 recalls · Class II, newest first
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
Failed Dissolution Specifications; 36 month stability timepoint
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Failed Dissolution Test Requirements
Subpotent; 15 month stability (by mfr)
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product