Abrams Royal Pharmacy Recalls Non-Sterile Mineral IV Injection
Abrams Royal Pharmacy is recalling 74 units of Mineral IV Injection found to contain Sphingomonas paucimobilis, indicating non-sterility.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Abrams Royal Pharmacy, Inc. is recalling 74 units of MINERAL IV Injection. The recall was initiated because analytical results indicated the product was non-sterile and contained Sphingomonas paucimobilis.
The affected product is identified by Lot number 11142013@74. The recall covers distribution nationwide and to Canada.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
- Manufacturer
- Abrams Royal Pharamacy
- Category
- Drug — Injectable
- Affected units
- 74
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 11142013@74
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Abrams Royal Pharamacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Abrams Royal Pharamacy
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FDA (Drugs) · 2014-09-03
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