Multi-event February 2019 FDA Recall Drug by Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy on February 21, 2019 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed in Dispensed in Oregon and the recall is currently terminated.

Reported Recall Events

D-1087-2019 TERMINATED D-1100-2019 TERMINATED D-1095-2019 TERMINATED D-1107-2019 TERMINATED D-1101-2019 TERMINATED D-1105-2019 TERMINATED D-1092-2019 TERMINATED D-1091-2019 TERMINATED D-1102-2019 TERMINATED D-1098-2019 TERMINATED D-1089-2019 TERMINATED D-1093-2019 TERMINATED D-1090-2019 TERMINATED D-1099-2019 TERMINATED D-1104-2019 TERMINATED D-1103-2019 TERMINATED D-1094-2019 TERMINATED D-1110-2019 TERMINATED D-1096-2019 TERMINATED D-1106-2019 TERMINATED D-1097-2019 TERMINATED D-1088-2019 TERMINATED D-1086-2019 TERMINATED D-1109-2019 TERMINATED D-1108-2019 TERMINATED

Recall Number: D-1087-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
12 prescriptions

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lots: 23012019@48, 24012019@2, 24012019@36, 28012019@35, 29012019@13, 05022019@5, 11022019@13, 12022019@20, 19022019@1, 19022019@6, 19022019@57, 19022019@61, All lots within expiry distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1100-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription, 9ml injectable

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:19022019@21, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1095-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
2 prescription 5ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lot 30102018@22, 15112018@5, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1107-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
3 prescriptions, 5ml injectable

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:20092018@41, 25092018@7, 27092018@3, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1101-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription, 5ml injectable

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:15112018@40 , distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1105-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
2 prescriptions, 5ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:26112018@68, 13122018@12, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1092-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
3 prescriptions 10, 9, ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lot:(a) 08102018@11, 27122018@33, (b) 30012019@43, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1091-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
5 prescriptions 5,10, 6, 9 ml injectable

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:(a) 10102018@30, (b) 31102018@33,05112018@1, (c)15012019@8, (d) 30012019@33, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1102-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription, 9ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:17012019@27, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1098-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
25 prescriptions 10, 9, ml injectable

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:(a) 26092018@22, 26092018@22, 09102018@47, 15102018@33, 15102018@33, 09102018@47, 15102018@33, 09102018@47, 29112018@4, 10122018@14, 29112018@4, 29112018@4, 19122018@20, 21122018@29, 21122018@29, 27122018@20, (b) 16012019@59, 18012019@17, 21012019@49, 21012019@49, 22012019@24, 22012019@24, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1089-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
4 prescriptions 9 & 10ml injectable

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lots: (a) 01112018@19, 04012019@52, 14022019@23, (b) 14012019@36, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1093-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
13 prescription 5, 6, 9, 10 ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lot: (a) 03102018@27, 07112018@18, 08112018@11, 16112018@15, 28112018@7, 14122018@37,16112018@41, 03012019@9, (b) 2012019@32, 23012019@59, (c)07022019@19, 07022019@1, (d)19122018@25, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1090-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
64 prescriptions 5, 10, 6 mL injections

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lot: (a) 18092018@52, 01102018@9, 05102018@36, 08102018@11, 102018@9, 01102018@9, 01102018@9, 03102018@27, 12102018@18, 01102018@9, 12102018@18, 12102018@18, 17102018@15, 12102018@18, 2102018@18, 22102018@31, 30102018@22, 29102018@9,29102018@9 29102018@9, 29102018@9, 12102018@18, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 11122018@7, 11122018@7, 28122018@11, 28122018@11, 28122018@11, 03012019@17, 03012019@17, 03012019@17, 08012019@21, 08012019@21,28082018@16 28082018@16, 28082018@16, 14092018@28, 14092018@28, 4092018@28, 14092018@28, 18092018@52, 18092018@52, 8092018@52, 18092018@52, 18092018@52, (b) 29102018@9, 03012019@17,14092018@28, (c) 11012019@64, 11012019@64, 11012019@64, 05022019@27, 5022019@27, 06022019@6, 06022019@6, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1099-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription 9ml injectable

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:15012019@10, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1104-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription 9ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:17012019@18, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1103-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
2 pre4scriptions 10 ml injections

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:09112018@55, 09012019@37, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1094-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
9 prescriptions 10, 9ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lot (a)17102018@15,14112018@3, 04122018@21, 14122018@15, 7122018@11, 28122018@69, 20092018@2, (b) 21012019@37, 22012019@31, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1110-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription, 5ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:13092018@44, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1096-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
2 prescription 5, 6.5 ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lot: (a) 22102018@31, (b) 09112018@33, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1106-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription, 18ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:12022019@23, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1097-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
3 prescription 5, 10 ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot: 05102018@36,27112018@49, (b) 28112018@54, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1088-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
6 prescriptions 10ml dropper bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lots: 17012019@13, 30012019@36, 01022019@4, 14022019@1, 19022019@18, 19022019@60, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1086-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription 20ml solution

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Batch or Lot Expiration Information

Lot# Lot: 12022019@30, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1109-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription, 5ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:19092018@1, distributed between 09-01-2018 to 02-20-2019.

Recall Number: D-1108-2019

Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Initiated
02-21-2019
Reported
04-17-2019
Quantity
1 prescription, 5ml injection

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82278
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.
Health Solutions Pharmacy Center Inc dba Professional 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Dispensed in Oregon
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Batch or Lot Expiration Information

Lot# Lot:06092018@57, distributed between 09-01-2018 to 02-20-2019.