The Recall Desk
SevereFDA (Drugs)·D-768-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Pentosan Injection Due to Sterility Concerns

Olympia Pharmacy is recalling three vials of compounded Pentosan 250 mg/ml 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectables) map to a score of 4 (Severe), as Class I is required for a score of 5.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling three vials of Pentosan 250 mg/ml Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the product.

The affected product includes lots K5629 (expiration date 11/30/13), C51013 (expiration date 9/10/13), and C5513 (expiration date 9/14/13). The product was distributed nationwide and in Puerto Rico.

Consumers and healthcare providers who have this product should stop using it and contact Olympia Pharmacy for further instructions or a refund. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
3

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 (2)

  • K5629 Exp 11/30/13
  • C51013 Exp 9/10/13 and C5513 Exp 9/14/13

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 failure

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