FDA (Drugs) recall action 83397

Wise Pharmacy recalled 11 products on 2019-08-07

The FDA (Drugs) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2019-08-07
Critical: 0
Units: 313

Why these products were recalled

Lack of Processing Controls

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–11 of 11

ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Compounded Papaverine/Phentolamine/Alprostadil Injectable Due to Processing Controls
Wise Pharmacy is recalling 32 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Product
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Distribution
3 states
ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Papaverine, Phentolamine, and Alprostadil Injectable Vials
Wise Pharmacy is recalling specific lots of compounded Papaverine/Phentolamine/Alprostadil injectable vials due to a lack of processing controls.
Product
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Distribution
3 states
ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Tobramycin Irrigation Solution Due to Processing Controls
Wise Pharmacy is recalling Tobramycin Irrigation 80 mg/1000 mL Solution due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Product
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Distribution
3 states
ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Dexamethasone Sodium Phosphate Injection Due to Processing Controls
Wise Pharmacy is recalling 27 vials of Dexamethasone Sodium Phosphate Injection because of a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Product
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Distribution
3 states
ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Papaverine, Phentolamine, and Alprostadil Injectable Vials
Wise Pharmacy is recalling 97 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls.
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.
Category
Distribution
3 states
ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Papaverine, Phentolamine, and Alprostadil Injectable Vials
Wise Pharmacy is recalling 84 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls.
Product
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.
Category
Distribution
3 states
ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Alprostadil Injectable Due to Lack of Processing Controls
Wise Pharmacy is recalling Alprostadil 100 mcg/mL Injectable vials due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Product
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Distribution
3 states
ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Gentamicin Irrigation Solution Due to Processing Controls
Wise Pharmacy is recalling Gentamicin Irrigation Solution due to a lack of processing controls. The affected product was distributed in Colorado, Texas, and Wyoming.
Product
Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Distribution
3 states
SevereFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Acetylcysteine Otic Drops Due to Processing Controls
Wise Pharmacy is recalling Acetylcysteine 2% Otic Drops due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Product
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Distribution
3 states
ModerateFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Papaverine/Phentolamine Injectable Due to Processing Controls
Wise Pharmacy is recalling 8 vials of Papaverine/Phentolamine Injectable due to lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
Product
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Distribution
3 states
SevereFDA (Drugs)··2019-08-07
Wise Pharmacy Recalls Compounded Papaverine Injectable Due to Processing Controls
Wise Pharmacy is recalling 14 vials of compounded Papaverine/Phentolamine/Alprostadil/Atropine injectable due to a lack of processing controls.
Product
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.
Category
Distribution
3 states