The Recall Desk
SevereFDA (Drugs)·D-774-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Potassium Phosphate Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Potassium Phosphate Injection because FDA inspections raised concerns about quality control and sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as lack of sterility assurance in injectable drugs are classified as Severe (Score 4), particularly when structural or process defects are identified by inspection.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Potassium Phosphate Injection. The product was distributed nationwide and in Puerto Rico. The specific product code is K5019 with an expiration date of 9/30/13.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the lack of assurance of sterility. The source text does not report any specific illnesses or injuries associated with this recall.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Potassium Phosphate Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injectable
Hazard
Affected units
1

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)

  • K5019 Exp 9/30/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy 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 105 products in this recall →

Related recalls

Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy

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Same hazard · sterility

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