Drug recall
17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium…
FDA recall event 64957 · Class II · Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Key facts
| Event ID | 64957 |
|---|---|
| Recall numbers | D-270-2013, D-271-2013, D-272-2013, D-273-2013, D-274-2013, D-275-2013, D-276-2013, D-277-2013, D-278-2013, D-279-2013, D-280-2013, D-281-2013 and 14 more |
| Recalling firm | Axium Healthcare Pharmacy dba Balanced Solutions Compounding |
| Product type | Drugs |
| Products | 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746, Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746, Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746, BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746, BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 and 21 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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…, Lack of Sterility Assurance |
| Initiation date | Apr 17, 2013 |
| Report date | May 1, 2013 |
| Termination date | Apr 19, 2017 |
| City | Lake Mary |
| State | FL |
| Country | United States |
| FEI number | 3003254930 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: