Class II · Moderate risk
All Unexpired Sterile Drug Products
Lack of Assurance of Sterility
MINERAL IV Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
- Recalling firm
- Abrams Royal Pharamacy
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1563-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Abrams Royal Pharamacy
All 2013 recallsOther sterility / contamination recalls from 2013
All sterility / contamination recalls
Class II · Moderate risk
All Unexpired Sterile Drug Products
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B-12 injections
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Class II · Moderate risk
Bupivacaine 3%
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Class II · Moderate risk
Sodium Bicarbonate 8.4%
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
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