Class II · Moderate risk Ongoing
Moxifloxacin PF
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
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Class II · Moderate risk Ongoing
Broncochem Cold & Tea
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk Ongoing
Broncochem Cold & Flu Syrup Kids
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class I · High risk Ongoing
Methocarbamol Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray USP
Reason CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II · Moderate risk Ongoing
Clobazam Tablets 10mg
Reason CGMP Deviations: Out of specification for residual solvents.
Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray USP 50mcg
Reason CGMP Deviations: potential presence of Burkholderia cepacia complex
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 II · Moderate risk Ongoing
Mesalamine Extended-Release Capsules
Reason Failed Dissolution Specifications: Out of specification for dissolution.
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 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 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 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 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.
Class II · Moderate risk Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Reason Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class III · Low risk Ongoing
Glimepiride Tablets
Reason Misprint on tablet