Multi-event January 2019 FDA Recall Drug by Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy on January 2, 2019 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed in Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling. and the recall is currently terminated.

Reported Recall Events

D-0400-2019 TERMINATED D-0397-2019 TERMINATED D-0403-2019 TERMINATED D-0407-2019 TERMINATED D-0401-2019 TERMINATED D-0405-2019 TERMINATED D-0396-2019 TERMINATED D-0398-2019 TERMINATED D-0408-2019 TERMINATED D-0392-2019 TERMINATED D-0395-2019 TERMINATED D-0394-2019 TERMINATED D-0393-2019 TERMINATED D-0399-2019 TERMINATED D-0406-2019 TERMINATED D-0402-2019 TERMINATED D-0404-2019 TERMINATED

Recall Number: D-0400-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
300 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Methocarbamol liquid 100mg/ml, RX, glass vial

Batch or Lot Expiration Information

Lot# 10082018@34 exp 1/6/19, 10312018@27 exp 1/29/19

Recall Number: D-0397-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
125 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Lidocaine gel 2%, RX, plastic dropper

Batch or Lot Expiration Information

Lot# 10222018@15

Recall Number: D-0403-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Cyclosporin liquid 1%, Rx, plastic dropper bottle

Batch or Lot Expiration Information

Lot# 07192018@12

Recall Number: D-0407-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Glutathione liquid, 200mg/ml, Rx

Batch or Lot Expiration Information

Lot# 10092018@5

Recall Number: D-0401-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
200 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Testosteron Cypionate liquid 200mg/ml, RX, glass vial

Batch or Lot Expiration Information

Lot# 10012018@54 exp 3/30/19

Recall Number: D-0405-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Cyclosporin liquid 0.2%, Rx, plastic dropper bottle

Batch or Lot Expiration Information

Lot# 10042018@10

Recall Number: D-0396-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
20 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial

Batch or Lot Expiration Information

Lot# 10252018@24

Recall Number: D-0398-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
50 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments

Batch or Lot Expiration Information

Lot# 08072018@30

Recall Number: D-0408-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Lidocaine gel 1%, RX, plastic dropper

Batch or Lot Expiration Information

Lot# 10222018@40

Recall Number: D-0392-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
830 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye

Batch or Lot Expiration Information

Lot# 08172018@7 exp 2/13/19, 09202018@16 exp 3/2/19, 10172018@32 exp 3/2/19.

Recall Number: D-0395-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
30 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
HCG liquid, 1000u/ml, RX, glass vial, various

Batch or Lot Expiration Information

Lot# 10162018@22

Recall Number: D-0394-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
60 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Glutathione liquid, 100mg/ml

Batch or Lot Expiration Information

Lot# 10292018@17

Recall Number: D-0393-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
50 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Epinephrine liquid 1:1000, RX, glass vial

Batch or Lot Expiration Information

Lot# 10102018@13 exp 1/8/19, 10222018@33 exp 1/20/19

Recall Number: D-0399-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
310 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial

Batch or Lot Expiration Information

Lot# 1) 10192018@8 exp 2/28/19, MIC Ba w/ aminos 2) 10292018@15 exp 1/31/19, MIC B

Recall Number: D-0406-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Cyclosporin liquid 0.05%, Rx, plastic dropper bottle

Batch or Lot Expiration Information

Lot# 10122018@30 11022018@18

Recall Number: D-0402-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
150 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Vitamin B12 liquid 1000mcg/ml, RX, glass vial

Batch or Lot Expiration Information

Lot# 10162018@28 exp 1/14/19, 10182018@38 exp 1/16/19

Recall Number: D-0404-2019

Reason for Recall
Lack of sterility assurance.
Initiated
01-02-2019
Reported
01-09-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81883
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.
Hiers Enterprises, LLC dba Northwest Compounding 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.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2023
Product Description About Product Description
Full technical description of the product.
Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

Batch or Lot Expiration Information

Lot# 07272018@2