Class II · Moderate risk Ongoing
Pain Wizard
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Pain Wizard
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Pain Wizard
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Aloe Gator
Reason Out of Specification for active ingredient
Class II · Moderate risk Ongoing
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with…
Reason Out of Specification for active ingredient
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Pain Wizard
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Completed
Gordofilm Wart Remover
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Eyesaline
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP
Reason CGMP Deviations
Class II · Moderate risk Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Class II · Moderate risk Completed
Methylergonovine Maleate Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
fentaNYL Citrate 2
Reason Lack of Assurance of Sterility: leaking bags
Class II · Moderate risk Terminated
Lactated Ringer's Injection USP
Reason Lack of assurance of sterility: bags have the potential to leak..
Class II · Moderate risk Terminated
Rifampin Capsules USP
Reason Subpotent Drug
Class II · Moderate risk Terminated
VCF Vaginal Contraceptive Film
Reason cGMP Diviations
Class II · Moderate risk Completed
Sterile Diluent
Reason CGMP Deviations
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