Class II · Moderate risk Ongoing
Equate Stye Lubricant Eye Ointment
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Equate Lubricant Eye Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pure Care Foaming Mint Hand Sanitizer 62%
Reason CGMP Deviations
Class II · Moderate risk Terminated
Febuxostat Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Norepinephrine Bitartrate in 5% Dextrose Injection
Reason Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class II · Moderate risk Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Reason Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II · Moderate risk Terminated
Equate Cherry Cough Drops
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
Kroger Cherry Cough Drops
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
Meijer Cherry Cough Drops
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
CVS Health Cherry Cough Drops
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
Omeza Skin Protectant
Reason CGMP Deviations
Class II · Moderate risk Terminated
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
Reason CGMP Deviations
Class II · Moderate risk Completed
Fexofenadine Hydrochloride Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Zolpidem Tartrate Extended-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Zolpidem Tartrate Extended-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Niacin Extended-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Niacin Extended-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Mesalamine Delayed-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Lurasidone Hydrochloride Tablets 120mg
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Lurasidone Hydrochloride Tablets 60mg
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Febuxostat Tablets 80 mg
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
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
Cinacalcet Tablets 60mg
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
Adrenalin
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.