CLASS I Drug recall · Reported 3 Sep 2014 · FDA Enforcement Report
Mineral IV Injection, compounded by Abrams Royal Pharmacy recalled
Abrams Royal Pharamacy is recalling Mineral IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX, distributed nationwide in the US. The recall was initiated on 19 Dec 2013 and the FDA has classified it as Class I.
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-1563-2014
- FDA event ID
- 67135
- Recalling firm
- Abrams Royal Pharamacy, Dallas, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Dec 2013
- FDA classified
- 25 Aug 2014
- Reported
- 3 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Dec 2013 | Recall initiated by company | |
| 25 Aug 2014 | Classified by FDA | +249 days |
| 3 Sep 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
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
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
Where it was distributed
Nationwide and to Canada
Questions about this recall
Is Mineral IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX recalled?
Yes. Abrams Royal Pharamacy recalled Mineral IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX on 19 Dec 2013. The recall is Class I and its status is Terminated. Recall number D-1563-2014.
Why was it recalled?
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Which lots are affected?
Lot number 11142013@74
Where was it sold?
Nationwide and to Canada
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abrams Royal Pharamacy
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | All Unexpired Sterile Drug Products recalled by Abrams Royal Pharamacy | Abrams Royal Pharamacy | Sterility | Nationwide |