Multi-event July 2019 FDA Recall Drug by Wise Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Wise Pharmacy on July 22, 2019 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed in CO, TX, WY and the recall is currently terminated.

Reported Recall Events

D-1573-2019 TERMINATED D-1576-2019 TERMINATED D-1574-2019 TERMINATED D-1568-2019 TERMINATED D-1567-2019 TERMINATED D-1572-2019 TERMINATED D-1571-2019 TERMINATED D-1570-2019 TERMINATED D-1575-2019 TERMINATED D-1569-2019 TERMINATED D-1577-2019 TERMINATED

Recall Number: D-1573-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
84 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : 6054N; 4796N, Exp 7/16/2019; 7049N, Exp 11/24/2019

Recall Number: D-1576-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
32 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : 6176N, Exp 8/30/2019; 7162N, Exp 10/20/2019

Recall Number: D-1574-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
44 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : 5333N, Exp 7/12/2019; 7000N, Exp 10/18/2019

Recall Number: D-1568-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the product.
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Batch or Lot Expiration Information

Lot# : 6981N, Exp 10/17/2019

Recall Number: D-1567-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the product.
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.

Batch or Lot Expiration Information

Lot# : 7131N, Exp 7/11/19

Recall Number: D-1572-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
8 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the product.
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Batch or Lot Expiration Information

Lot# : 5978N, Exp 8/20/2019; 7266N, Exp 11/5/2019

Recall Number: D-1571-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
1 container

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the product.
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Batch or Lot Expiration Information

Lot# : 7270N, Exp 7/22/2019

Recall Number: D-1570-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
1 container

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : 7179N, Exp 7/16/2019

Recall Number: D-1575-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
97 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# : 5620N, Exp 7/16/2019; 6221N, Exp 8/31/2019; 6952N, Exp 10/16/2019

Recall Number: D-1569-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
27 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lots #: 5506N, Exp 9/21/2019; 7180N, Exp 12/29/2019

Recall Number: D-1577-2019

Reason for Recall
Lack of Processing Controls
Initiated
07-22-2019
Reported
08-07-2019
Quantity
14 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wise Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, TX, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : 6153N, Exp8/29/2019