CLASS II Drug recall · Reported 3 Sep 2014 · FDA Enforcement Report
All Unexpired Sterile Drug Products recalled by Abrams Royal Pharamacy
Abrams Royal Pharamacy is recalling All Unexpired Sterile Drug Products, 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 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-1564-2014
- FDA event ID
- 67135
- Recalling firm
- Abrams Royal Pharamacy, Dallas, TX
- Classification
- Class II
- 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
- Compounded 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
Lack of Assurance of Sterility
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
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
Where it was distributed
Nationwide and to Canada
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All unexpired lots of sterile drug products
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 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
1 other product · FDA event 67135This product is part of a recall event; the main page for the event is Mineral IV Injection, compounded by Abrams Royal Pharmacy recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Mineral IV Injection, compounded by Abrams Royal Pharmacy recalled | Abrams Royal Pharamacy | Sterility | Nationwide |
More recalls from Abrams Royal Pharamacy
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Mineral IV Injection, compounded by Abrams Royal Pharmacy recalled | Abrams Royal Pharamacy | Sterility | Nationwide |