Multi-event July 2018 FDA Recall Drug by Ranier's Compounding Laboratory

This Multi-event Class II drug recall was voluntarily initiated by Ranier's Compounding Laboratory on July 25, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was distributed within the state of Pennsylvania. and the recall is currently terminated.

Reported Recall Events

D-1082-2018 TERMINATED D-1091-2018 TERMINATED D-1086-2018 TERMINATED D-1083-2018 TERMINATED D-1084-2018 TERMINATED D-1081-2018 TERMINATED D-1088-2018 TERMINATED D-1094-2018 TERMINATED D-1080-2018 TERMINATED D-1087-2018 TERMINATED D-1085-2018 TERMINATED D-1093-2018 TERMINATED D-1089-2018 TERMINATED D-1092-2018 TERMINATED D-1090-2018 TERMINATED

Recall Number: D-1082-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
213 prefilled syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1091-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1086-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
a) 2 vials; b) 1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1083-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
a) 1 vial; b) 1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1084-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1081-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
1 droptainer

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1088-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
1 droptainer

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1094-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1080-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
5 droptainers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1087-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1085-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
60 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1093-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1089-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
1 droptainer

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots with expiry

Recall Number: D-1092-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-1090-2018

Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Initiated
07-25-2018
Reported
08-22-2018
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80633
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.
Ranier's Compounding Laboratory
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 within the state of Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2022
Product Description About Product Description
Full technical description of the product.
P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Batch or Lot Expiration Information

Lot# All lots within expiry