The Recall Desk
CriticalFDA (Drugs)·D-1563-2014·Announced 2014-09-03

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard
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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Same hazard · non sterility

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