Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy…
Reason Lack of Processing Controls
Is Phentolamine recalled?
322 FDA recalls mention Phentolamine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phentolamine.
Class II · Moderate risk Terminated
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded…
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj…
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996 NW…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
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