Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
FDA recall notice · announced August 7, 2019 · Wise Pharmacy
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Reason for recall
Lack of Processing Controls
Notes
Distribution: CO, TX, WY
Lot/code information: Lot #: 5620N, Exp 7/16/2019; 6221N, Exp 8/31/2019; 6952N, Exp 10/16/2019
Quantity: 97 vials
Status: Terminated
Products in this recall event:
- Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1567-2019)
- Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1576-2019)
- Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1577-2019)
- Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1574-2019)
- Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1573-2019)
- Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1572-2019)
- Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1569-2019)
- Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1571-2019)
- Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1570-2019)
- Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1568-2019)
- Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. (D-1575-2019)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.