Drug recall
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
FDA recall event 67135 · Class I, Class II · Abrams Royal Pharamacy
Key facts
| Event ID | 67135 |
|---|---|
| Recall numbers | D-1563-2014, D-1564-2014 |
| Recalling firm | Abrams Royal Pharamacy |
| Product type | Drugs |
| Products | All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX, MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX |
| Classification | Class I, Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility, Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis |
| Initiation date | Dec 19, 2013 |
| Report date | Sep 3, 2014 |
| Termination date | Oct 7, 2016 |
| City | Dallas |
| State | TX |
| Country | United States |
| FEI number | 1000138425 |
At a glance
- 1–9 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: