Class II · Moderate risk Terminated
Age Back
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
FDA Drug Recalls
14,450 recalls · Class II, newest first
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 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
Class II · Moderate risk Terminated
Gabapentin Capsules
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Acetaminophen and Codeine Phosphate Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Acetaminophen and Codeine Phosphate Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Acetaminophen and Codeine Phosphate Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
fentaNYL Citrate Injection 50 mcg per mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
fentaNYL Citrate Injection
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL…
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
fentaNYL Citrate 50 mcg per mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.