Multi-event December 2022 FDA Recall Drug by Northern Va Compounders Pllc

This Multi-event Class II drug recall was voluntarily initiated by Northern Va Compounders Pllc on December 30, 2022 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0121-2023 TERMINATED D-0109-2023 TERMINATED D-0103-2023 TERMINATED D-0126-2023 TERMINATED D-0110-2023 TERMINATED D-0112-2023 TERMINATED D-0114-2023 TERMINATED D-0125-2023 TERMINATED D-0102-2023 TERMINATED D-0123-2023 TERMINATED D-0122-2023 TERMINATED D-0116-2023 TERMINATED D-0111-2023 TERMINATED D-0105-2023 TERMINATED D-0118-2023 TERMINATED D-0106-2023 TERMINATED D-0113-2023 TERMINATED D-0107-2023 TERMINATED D-0104-2023 TERMINATED D-0115-2023 TERMINATED D-0117-2023 TERMINATED D-0119-2023 TERMINATED D-0124-2023 TERMINATED D-0120-2023 TERMINATED D-0108-2023 TERMINATED

Recall Number: D-0121-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
8 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11252022@15, Exp 1/9/2023; 11302022@9, Exp 1/14/2023; 12022022@5, Exp 1/16/2023

Recall Number: D-0109-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 12012022@7, Exp 1/15/2023

Recall Number: D-0103-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
78 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11182022@1, Exp 1/2/2023; 12012022@9, Exp 1/15/2023; 11142022@8, Exp 12/29/2022; 11292022@10, Exp 1/13/2023

Recall Number: D-0126-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11212022@8, Exp 1/5/2023

Recall Number: D-0110-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11212022@5, Exp 1/5/2023

Recall Number: D-0112-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 12052022@11, Exp 1/19/2023

Recall Number: D-0114-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11142022@11, Exp 12/29/2022

Recall Number: D-0125-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
1200 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 10252022@3, Exp 1/31/2023

Recall Number: D-0102-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 12062022@7, Exp 1/20/2023; 12072022@32, Exp 1/22/2023

Recall Number: D-0123-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
36 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 12062022@4, Exp 1/20/2023

Recall Number: D-0122-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 12062022@3, Exp 1/20/2023

Recall Number: D-0116-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11212022@7, Exp 1/5/2023

Recall Number: D-0111-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
108 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11252022@12, Exp 1/9/2023

Recall Number: D-0105-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
56 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11162022@7, Exp 12/31/2022

Recall Number: D-0118-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
8 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11262022@8, Exp 1/10/2023; 11302022@12, Exp 1/14/2023

Recall Number: D-0106-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
750 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11142022@17, Exp 12/29/2022; 11262022@7, Exp 1/10/2023; 12022022@3, Exp 1/16/2023

Recall Number: D-0113-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11142022@12, Exp 12/29/2022

Recall Number: D-0107-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
39 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11162022@10, Exp 12/31/2022; 12052022@9, Exp 1/19/2023

Recall Number: D-0104-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
12 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 12012022@11, Exp 1/15/2023

Recall Number: D-0115-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11182022@2, Exp 1/2/2023

Recall Number: D-0117-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
525 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11252022@5, Exp 1/9/2023; 12012022@12, Exp 1/15/2023

Recall Number: D-0119-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11292022@16, Exp 1/13/2023

Recall Number: D-0124-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 12082022@8, Exp 1/22/2023

Recall Number: D-0120-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 11292022@12, Exp 1/13/2023

Recall Number: D-0108-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-30-2022
Reported
01-18-2023
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91443
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.
Northern VA Compounders PLLC
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Batch or Lot Expiration Information

Lot# : 12062022@1, Exp 1/20/2023