Class II · Moderate risk Ongoing
Humanrace Suncare
Reason Subpotent Drug: Product does not contain SPF that is declared on the label.
FDA Drug Recalls
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Class II · Moderate risk Ongoing
Humanrace Suncare
Reason Subpotent Drug: Product does not contain SPF that is declared on the label.
Class II · Moderate risk Ongoing
All Over-The-Counter
Reason CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
Class III · Low risk Ongoing
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg
Reason Subpotent: Out of Specification for Assay Test at the 3-month time point.
Class I · High risk Ongoing
Vegetal Vigra
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class III · Low risk Ongoing
Tobramycin Opthalmic Solution USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Oxacillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Oxacillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Oxacillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Fingolimod Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Big Machine Distillery Hand Sanitizer Non-Sterile Solution…
Reason CGMP Deviation: impurities exceed allowable limits.
Class II · Moderate risk Ongoing
Tizanidine Hydrochloride Tablet 4mg
Reason Failed Stability Specifications
Class III · Low risk Ongoing
Pancreaze
Reason Failed Stability Specifications
Class II · Moderate risk Ongoing
Diclofenac Sodium Topical Solution USP
Reason Defective Delivery System
Class II · Moderate risk Ongoing
Tizanidine Tablets USP
Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk Ongoing
Dry Eye Relief Lubricant Eye Drops
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk Ongoing
Original Eye Drops
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class III · Low risk Ongoing
Tranexamic Acid USP Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Reason Sub-potent Drug
Class II · Moderate risk Ongoing
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Ongoing
Safe tussin PM
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.