Drug recall: TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare…
Class II FDA enforcement event 64957. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Axium Healthcare Pharmacy dba Balanced Solutions Compounding started this drug recall on 17 Apr 2013. The firm address in the FDA record is in Lake Mary, FL. FDA put the recall in Class II. FDA event 64957 has 26 product records. The first FDA enforcement report date is 1 May 2013. The record gives the status Terminated, with the termination date 19 Apr 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
CO, GA, MI, and Puerto Rico
Recalling firm
Axium Healthcare Pharmacy dba Balanced Solutions Compounding, Lake Mary, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
26 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-270-2013 | TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 380 vials (5 mL and 10 mL vials) | Class II | Terminated | 1 May 2013 |
| D-271-2013 | Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 326 vials (10 mL each) | Class II | Terminated | 1 May 2013 |
| D-272-2013 | Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 286 vials (30 mL vials each) | Class II | Terminated | 1 May 2013 |
| D-273-2013 | Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 401 vials (10 mL vials each) | Class II | Terminated | 1 May 2013 |
| D-274-2013 | Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 28 vials (10 mL each) | Class II | Terminated | 1 May 2013 |
| D-275-2013 | Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 15 vials ((30 mL each) | Class II | Terminated | 1 May 2013 |
| D-276-2013 | Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 29 vials (9 mL and 30 mL) | Class II | Terminated | 1 May 2013 |
| D-277-2013 | Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 11 vials (10 mL each) | Class II | Terminated | 1 May 2013 |
| D-278-2013 | Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 12 vials (15 mL each) | Class II | Terminated | 1 May 2013 |
| D-279-2013 | Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 5 vials (3 mL each) | Class II | Terminated | 1 May 2013 |
| D-280-2013 | Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 10 vials (30 mL each) | Class II | Terminated | 1 May 2013 |
| D-281-2013 | Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 15 vials (10 mL each) | Class II | Terminated | 1 May 2013 |
| D-282-2013 | Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 61 vials (5 mL and 10 mL vials) | Class II | Terminated | 1 May 2013 |
| D-283-2013 | BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Class II | Terminated | 1 May 2013 | |
| D-284-2013 | BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 6 vials (5 mL and 10 mL each) | Class II | Terminated | 1 May 2013 |
| D-285-2013 | Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 3 vials (10 mL vials) | Class II | Terminated | 1 May 2013 |
| D-286-2013 | 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 4 vials (5 mL each) | Class II | Terminated | 1 May 2013 |
| D-287-2013 | QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 3 vials (10 mL each) | Class II | Terminated | 1 May 2013 |
| D-288-2013 | DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 2 50 mL vials | Class II | Terminated | 1 May 2013 |
| D-289-2013 | Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Class II | Terminated | 1 May 2013 | |
| D-290-2013 | Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 172 vials (5 mL vials each) | Class II | Terminated | 1 May 2013 |
| D-291-2013 | Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 18 viasl (10 mL each) | Class II | Terminated | 1 May 2013 |
| D-292-2013 | HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 1 vial (10 mL) | Class II | Terminated | 1 May 2013 |
| D-293-2013 | Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 5 vials (30 mL each) | Class II | Terminated | 1 May 2013 |
| D-294-2013 | BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 1 vial (10 mL) | Class II | Terminated | 1 May 2013 |
| D-295-2013 | Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 1 vial (15 mL) | Class II | Terminated | 1 May 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class II
- 56%
- Product records in this event
- 26
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-270-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 64957. https://recallregister.com/fda/ii/64957/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
CO, GA, MI, and Puerto Rico
- What quantity of product is in FDA event 64957?
- The event has 26 product records. The first record gives this quantity:
380 vials (5 mL and 10 mL vials)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 56% of the 370 drug events that started in 2013 are in Class II.