Class I · High risk Terminated
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%
Reason Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
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Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Class II · Moderate risk Terminated
HEB 50% Isopropyl Alcohol First Aid Antiseptic
Reason Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
Class II · Moderate risk Terminated
Paliperidone Extended-Release Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Clotrimazole and Betamethasone Dipropionate Cream USP
Reason Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of sterility assurance: leaking bags
Class II · Moderate risk Terminated
hydrALAZINE HCl Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II · Moderate risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason Impurity failure at 0-time of the repackaged lot.
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP deviations
Class II · Moderate risk Terminated
Dexamethasone Elixir
Reason Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class III · Low risk Terminated
Sapropterin Dihydrochloride Powder for Oral Solution
Reason Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution USP 0.5%
Reason Failed impurities/degradation specifications
Class II · Moderate risk Terminated
Olanzapine Tablets
Reason cGmp Deviations
Class II · Moderate risk Terminated
Amlodipine and Olmesartan Medoxomil Tablets
Reason cGMP deviations
Class II · Moderate risk Terminated
Pyrazinamide Tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason cGMP Deviations
Class III · Low risk Terminated
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%
Reason Subpotent drug
Class I · High risk Terminated
Hcg 6
Reason Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Class I · High risk Terminated
RISE UP RED EDITION Capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
Avaphinal Maximum Male Enhancement Sexual Pills
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk Terminated
Diazepam Oral Solution
Reason Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Class I · High risk Terminated
RED MAMMOTH capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.