CLASS II Drug recall · Reported 1 May 2013 · FDA Enforcement Report
Methylprednisolone Acetate injectable Balanced Solutions recalled
Axium Healthcare Pharmacy is recalling Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division, distributed in Colorado, Georgia, Michigan, Puerto Rico. The recall was initiated on 17 Apr 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-271-2013
- FDA event ID
- 64957
- Recalling firm
- Axium Healthcare Pharmacy, Lake Mary, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Apr 2013
- FDA classified
- 23 Apr 2013
- Reported
- 1 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Apr 2013 | Recall initiated by company | |
| 23 Apr 2013 | Classified by FDA | +6 days |
| 1 May 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it was distributed
CO, GA, MI, and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All Lots
Where was it sold?
CO, GA, MI, and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
25 other products · FDA event 64957This product is part of a recall event; the main page for the event is Trimix Customs Injectable Balanced Solutions recalled.
More recalls from Axium Healthcare Pharmacy
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Progesterone in Olive Oil Injectable Balanced Solutions recalled | Axium Healthcare Pharmacy | Sterility | 4 states |
| Drug | CLASS II | Comprehensive injection #4 - SS varied injectable Balanced recalled | Axium Healthcare Pharmacy | Sterility | 4 states |
| Drug | CLASS II | BiMix Standard Injectable Balanced Solutions recalled | Axium Healthcare Pharmacy | Sterility | 4 states |
| Drug | CLASS II | Sodium Tetradecyl Sulfate Injectable Balanced Solutions recalled | Axium Healthcare Pharmacy | Sterility | 4 states |
| Drug | CLASS II | 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced recalled | Axium Healthcare Pharmacy | Sterility | 4 states |