Class II · Moderate risk Terminated
Infuvite Adult Multiple vitamins injection
Reason cGMP Deviations: Products were stored outside the drug label specifications.
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Class II · Moderate risk Terminated
Rocuronium Bromide Injection
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Class I · High risk Ongoing
Arize Herbal Dietary Supplement
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I · High risk Ongoing
SCHWINNNG Herbal Dietary Supplement
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I · High risk Ongoing
Sustain Herbal Dietary Supplement
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class II · Moderate risk Ongoing
Terlivaz
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II · Moderate risk Ongoing
Acthar Gel
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class I · High risk Terminated
Neptune's Fix
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class II · Moderate risk Ongoing
Mesalamine Extended-Release Capsules
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk Terminated
Voriconazole for Oral Suspension
Reason Labeling: Incorrect or Missing Package Insert
Class II · Moderate risk Completed
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Reason Subpotent Drug: Out of specification for assay
Class I · High risk Ongoing
To the Moon Capsules
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk Ongoing
Ram It
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk Completed
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid
Reason Chemical Contamination; presence of benzene.
Class III · Low risk Ongoing
HydrALAZINE Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP
Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Class II · Moderate risk Ongoing
Lubricant PM Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
CVS Health Lubricant Eye Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Equate Stye Lubricant Eye Ointment
Reason Lack of Assurance of Sterility
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 III · Low risk Ongoing
Nortrel 7/7/7
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk Ongoing
Nortrel
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
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.