Class II · Moderate risk
Benadryl
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Alka Seltzer
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Aleve 1's
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Advil a) Ibuprofen
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class I · High risk
Rheumacare capsules
CGMP Deviations: product found to contain lead.
Class II · Moderate risk
Sterile Water for Irrigation
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Class III · Low risk
Diclofenac Sodium Topical Gel
Failed PH Specifications
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class III · Low risk
traZODONE Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Tri-Moxi+¿
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Dexamethasone Moxifloxacin
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
BD ChloraPrep" Triple Swabsticks
Lack of Assurance of Sterlity
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class III · Low risk
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class I · High risk
MR. 7 SUPER 700000 capsules
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Class III · Low risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class I · High risk
ClearLife Allergy Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I · High risk
ReBoost Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class II · Moderate risk
Noxafil Powdermix
Presence of particulate matter: potential presence of metal particulates in the product.
Class II · Moderate risk
Merck Emend
Presence of particulate matter: potential presence of metal particulates in the product.
Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint