Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent and Subpotent
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Furosemide Tablets
Reason Presence of Foreign Substance
Class II · Moderate risk Ongoing
Aq 120 Gfew
Reason cGMP deviations.
Class II · Moderate risk Ongoing
Lanreotide Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Ongoing
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
CHNaO Fluorescein Sodium Ophthalmic Strips
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Vista Gonio Eye Lubricant
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced…
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Vista Gel Hypromellose USP 0.3% w/v
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Vista Tears Polyethylene Glycol 400 0.4% w/v
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Rosuvastatin Tablets
Reason Out of specification for dissolution.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class II · Moderate risk Ongoing
Icosapent Ethyl capsules
Reason Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Class III · Low risk Ongoing
Fluocinolone Acetonide Solution Topical Solution USP
Reason Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Class II · Moderate risk Ongoing
Ondansetron Orally Disintegrating Tablets
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk Ongoing
TPN bag
Reason Incorrect Product Formulation: product did not contain insulin as listed in the label.
Class III · Low risk Ongoing
parodontax
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Class II · Moderate risk Ongoing
Toothpaste: a) COLGATE
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Deodorant: a) Axe
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Petroleum jelly: a) Vaseline Petroleum Jelly
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Lucky Ice
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Personal Care
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Carmex a) jar
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Personal Care
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.