Class II · Moderate risk Completed
Sterile Diluent
Reason CGMP Deviations
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Infumorph
Reason The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class II · Moderate risk Terminated
Tri-Lo-Sprintec
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Potassium Chloride for Injection Concentrate USP
Reason Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Class II · Moderate risk Terminated
Betimol
Reason Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Class I · High risk Ongoing
Treprostinil Injection
Reason Presence of Particulate Matter.
Class III · Low risk Terminated
Digoxin Tablets
Reason Cross Contamination with Other Products:(mycophenolate mofetil).
Class II · Moderate risk Ongoing
Febuxostat Tablets 80mg
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Ongoing
Febuxostat Tablets 40mg
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
S.P Labs
Reason Failed Stability Specifications
Class II · Moderate risk Completed
S.P.Labs
Reason Failed Stability Specifications
Class II · Moderate risk Ongoing
FentaNYL citrate
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk Ongoing
Phenylephrine HCl
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk Ongoing
hyalogic For Dry Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Red Eye Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Pink Eye Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Aging Eye Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Floaters Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Eye strain Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Dryness Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Eye Twitching Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Blur Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Allergy Eyes Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tobramycin for Injection
Reason Failed Stability Specification: Water determination was found not complying with specification.
Class II · Moderate risk Ongoing
Nicardipine Hydrochloride Injection
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities