Multi-event April 2013 FDA Recall Drug by Axium Healthcare Pharmacy Dba Balanced Solutions Compounding

This Multi-event Class II drug recall was voluntarily initiated by Axium Healthcare Pharmacy Dba Balanced Solutions Compounding on April 17, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in CO, GA, MI, and Puerto Rico and the recall is currently terminated.

Reported Recall Events

D-286-2013 TERMINATED D-272-2013 TERMINATED D-271-2013 TERMINATED D-289-2013 TERMINATED D-295-2013 TERMINATED D-280-2013 TERMINATED D-277-2013 TERMINATED D-275-2013 TERMINATED D-292-2013 TERMINATED D-282-2013 TERMINATED D-294-2013 TERMINATED D-279-2013 TERMINATED D-291-2013 TERMINATED D-283-2013 TERMINATED D-278-2013 TERMINATED D-274-2013 TERMINATED D-290-2013 TERMINATED D-285-2013 TERMINATED D-284-2013 TERMINATED D-288-2013 TERMINATED D-287-2013 TERMINATED D-293-2013 TERMINATED D-273-2013 TERMINATED D-281-2013 TERMINATED D-276-2013 TERMINATED D-270-2013 TERMINATED

Recall Number: D-286-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
4 vials (5 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-272-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
286 vials (30 mL vials each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-271-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
326 vials (10 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-289-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-295-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
1 vial (15 mL)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-280-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
10 vials (30 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-277-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
11 vials (10 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-275-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
15 vials ((30 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-292-2013

Reason for Recall
Lack of Sterility Assurance
Initiated
04-17-2013
Reported
05-01-2013
Quantity
1 vial (10 mL)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-282-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
61 vials (5 mL and 10 mL vials)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-294-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
1 vial (10 mL)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-279-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
5 vials (3 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-291-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
18 viasl (10 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-283-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-278-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
12 vials (15 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-274-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
28 vials (10 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-290-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
172 vials (5 mL vials each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-285-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
3 vials (10 mL vials)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-284-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
6 vials (5 mL and 10 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-288-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
2 50 mL vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-287-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
3 vials (10 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-293-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
5 vials (30 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-273-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
401 vials (10 mL vials each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-281-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
15 vials (10 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# ALL Lots

Recall Number: D-276-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
29 vials (9 mL and 30 mL)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-270-2013

Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Initiated
04-17-2013
Reported
05-01-2013
Quantity
380 vials (5 mL and 10 mL vials)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64957
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.
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, MI, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2017
Product Description About Product Description
Full technical description of the product.
TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Batch or Lot Expiration Information

Lot# All Lots