Class II · Moderate risk Terminated
De-Fibroidin
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Cellulite Off
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Blood Clot Purger
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Bleeding Stop
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Asthma Chest Rub
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Asma Stopper
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Age Stop Ex
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Age Back
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Acne Off
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Acne Cystic
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Acupuncture
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class I · High risk Terminated
Tetracycline HCL Capsules
Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class I · High risk Terminated
Tetracycline HCL Capsules
Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class III · Low risk Terminated
Tacrolimus Capsules
Reason Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Class II · Moderate risk Terminated
Dermatone
Reason Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class II · Moderate risk Terminated
Dermatone
Reason Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class II · Moderate risk Terminated
Draximage Dtpa
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Nystatin Oral Suspension
Reason SubPotent Drug: Low out-of-specification results for assay testing.
Class II · Moderate risk Terminated
Ceftazidime Sterile Ophthalmic Solution for Injection…
Reason Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class II · Moderate risk Terminated
Methotrexate
Reason Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class II · Moderate risk Terminated
Oxycodone and Acetaminophen Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Phentermine Hydrochloride Capsules
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Mirtazapine Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Simvastatin Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Levetiracetam Tablets USP 750 mg 120-count bottles
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed