Class II · Moderate risk Terminated
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05
Reason Lack of Assurance of Sterility
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
Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houston, Texas…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1308-03
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston, Texas…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1354-03
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine…
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns…
Class II · Moderate risk Terminated
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin…
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns…
Class II · Moderate risk Terminated
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns…
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