Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise…
Reason Lack of Processing Controls
Is Alprostadil recalled?
165 FDA recalls mention Alprostadil. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alprostadil.
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy…
Reason Lack of Processing Controls
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
Class II · Moderate risk Terminated
Alprostadil 100 mcg/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
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc…
Reason Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
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
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 Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Reason Incorrect Product Formulation
Class II · Moderate risk Terminated
Alprostadil 20 mcg/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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