Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.16-0.57mg-19.45mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
FDA Drug Recalls
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Class II · Moderate risk
Papaverine-Phentolamine-Pge1 12-1mg-10mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 30-1 Mg-10 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine 30-1 Mg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Pge1 40 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 22-0.8 Mg-8 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250 Mg/Ml Oil* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Acetyl-L-Cysteine 10% P.F. Ophth Solution
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Dexamethasone
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class III · Low risk
Oxybutynin Chloride
Failed Dissolution Specifications
Class II · Moderate risk
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral…
Cross Contamination: Presence of IPA in finished product.
Class III · Low risk
Lovastatin Tablets USP
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class II · Moderate risk
Cefuroxime 10 mg/mL in Sodium Chloride
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class III · Low risk
Temozolomide Capsules
Failed dissolution specifications
Class II · Moderate risk
Etomidate Injection
Subpotent Drug.
Class II · Moderate risk
Dimercaptopropanesulfonate Sodium
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Class I · High risk
Maeng Da Kratom
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk
White Vein Kratom
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk
White Vein Kratom
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk
Maeng Da Kratom
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class III · Low risk
Lovastatin Tablets USP
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class III · Low risk
Ciclopirox shampoo 1%
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing