Multi-event March 2020 FDA Recall Drug by Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy on March 26, 2020 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Patient Distribution list includes addresses in the following states: CA, ME, TX and the recall is currently terminated.

Reported Recall Events

D-1099-2020 TERMINATED D-1097-2020 TERMINATED D-1098-2020 TERMINATED D-1096-2020 TERMINATED D-1095-2020 TERMINATED

Recall Number: D-1099-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-26-2020
Reported
04-15-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85351
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.
Innovative Intrathecal Solutions, Inc. dba Innovative 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.
Patient Distribution list includes addresses in the following states: CA, ME, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2024
Product Description About Product Description
Full technical description of the product.
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Batch or Lot Expiration Information

Lot# 02282020@30, Expires after 04/28/2020

Recall Number: D-1097-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-26-2020
Reported
04-15-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85351
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.
Innovative Intrathecal Solutions, Inc. dba Innovative 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.
Patient Distribution list includes addresses in the following states: CA, ME, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2024
Product Description About Product Description
Full technical description of the product.
Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Batch or Lot Expiration Information

Lot# : 02212020@2, Expires after 04-21-2020
Lot# : 02262020@52 Expires after 04-26-2020

Recall Number: D-1098-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-26-2020
Reported
04-15-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85351
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.
Innovative Intrathecal Solutions, Inc. dba Innovative 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.
Patient Distribution list includes addresses in the following states: CA, ME, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2024
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Batch or Lot Expiration Information

Lot# : 11152019@41,Expires after 04-07-2020
Lot# 12042019@12, Expires after 04-26-2020
Lot# 12172019@9, Expires after 05-09-2020
Lot# 01032020@49, Expires after 05-26-2020
Lot# 01162020@55, Expires after 06-08-2020

Recall Number: D-1096-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-26-2020
Reported
04-15-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85351
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.
Innovative Intrathecal Solutions, Inc. dba Innovative 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.
Patient Distribution list includes addresses in the following states: CA, ME, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2024
Product Description About Product Description
Full technical description of the product.
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Batch or Lot Expiration Information

Lot# : 03022020@64, Expires after 05-18-2020
Lot# 01032020@51, Expires after 04-02-2020

Recall Number: D-1095-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-26-2020
Reported
04-15-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85351
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.
Innovative Intrathecal Solutions, Inc. dba Innovative 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.
Patient Distribution list includes addresses in the following states: CA, ME, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2024
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Batch or Lot Expiration Information

Lot# : 02262020@51, Expires after 05-26-2020
Lot# 01032020@53, Expires after 04-02-2020
Lot# 01162020@57, Expires after 04-15-2020