Class II · Moderate risk Ongoing
Aloe Gator
Reason Out of Specification for active ingredient
FDA Drug Recalls
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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
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 III · Low risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Reason Out of specification for assay
Class II · Moderate risk Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile…
Reason Subpotent Drug
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class I · High risk Ongoing
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk Ongoing
Javygtor
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Class III · Low risk Terminated
Cyclophosphamide for Injection
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk Terminated
Cyclophosphamide for Injection
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class II · Moderate risk Terminated
Eyesaline
Reason CGMP Deviations
Class I · High risk Terminated
Atovaquone Oral Suspension USP
Reason Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.