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.
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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
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 II · Moderate risk
Ephedrine Sulfate
Lack of assurance of sterility.
Class II · Moderate risk
BromSite (bromfenac ophthalmic solution)
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class II · Moderate risk
Lidocaine gel 1%
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.05%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.2%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.5%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 1%
Lack of sterility assurance.
Class II · Moderate risk
Vitamin B12 liquid 1000mcg/ml
Lack of sterility assurance.
Class II · Moderate risk
Testosteron Cypionate liquid 200mg/ml
Lack of sterility assurance.
Class II · Moderate risk
Methocarbamol liquid 100mg/ml
Lack of sterility assurance.
Class II · Moderate risk
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine/Epinepherine liquid 1%/ 1:1000
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine gel 2%
Lack of sterility assurance.
Class II · Moderate risk
Hydroxyprogesterone liquid
Lack of sterility assurance.