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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64957

26 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 17, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

26 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 26

TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-270-2013
Recall number
D-270-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
380 vials (5 mL and 10 mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 2 of 26

Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-271-2013
Recall number
D-271-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
326 vials (10 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 3 of 26

Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-272-2013
Recall number
D-272-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
286 vials (30 mL vials each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 4 of 26

Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-273-2013
Recall number
D-273-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
401 vials (10 mL vials each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 5 of 26

Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-274-2013
Recall number
D-274-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
28 vials (10 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 6 of 26

Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-275-2013
Recall number
D-275-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
15 vials ((30 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 7 of 26

Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-276-2013
Recall number
D-276-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
29 vials (9 mL and 30 mL)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 8 of 26

Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-277-2013
Recall number
D-277-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
11 vials (10 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 9 of 26

Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-278-2013
Recall number
D-278-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
12 vials (15 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 10 of 26

Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-279-2013
Recall number
D-279-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
5 vials (3 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 11 of 26

Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-280-2013
Recall number
D-280-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
10 vials (30 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 12 of 26

Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-281-2013
Recall number
D-281-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
15 vials (10 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 13 of 26

Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-282-2013
Recall number
D-282-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
61 vials (5 mL and 10 mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 14 of 26

BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-283-2013
Recall number
D-283-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 15 of 26

BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-284-2013
Recall number
D-284-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
6 vials (5 mL and 10 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 16 of 26

Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-285-2013
Recall number
D-285-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
3 vials (10 mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 17 of 26

17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-286-2013
Recall number
D-286-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
4 vials (5 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 18 of 26

QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-287-2013
Recall number
D-287-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
3 vials (10 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 19 of 26

DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-288-2013
Recall number
D-288-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
2 50 mL vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 20 of 26

Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-289-2013
Recall number
D-289-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 21 of 26

Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-290-2013
Recall number
D-290-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
172 vials (5 mL vials each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 22 of 26

Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-291-2013
Recall number
D-291-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
18 viasl (10 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 23 of 26

HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-292-2013
Recall number
D-292-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
1 vial (10 mL)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 24 of 26

Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-293-2013
Recall number
D-293-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
5 vials (30 mL each)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 25 of 26

BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-294-2013
Recall number
D-294-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
1 vial (10 mL)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico

drug · product 26 of 26

Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

D-295-2013
Recall number
D-295-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Quantity
1 vial (15 mL)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

ALL Lots

Distribution pattern

CO, GA, MI, and Puerto Rico