The Recall Desk
SevereFDA (Drugs)·D-767-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Pento-Gluc Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Pento-Gluc 200 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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 are assigned a score of 4 (Severe), particularly when involving significant risks such as sterility issues in injectable medications.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Pento-Gluc 200 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during the compounding of the product.

The specific hazard identified is a lack of assurance of sterility. The affected product is identified by the code B0521 and has an expiration date of 8/21/13. The product was distributed nationwide and in Puerto Rico.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Pento-Gluc 200 mg/ml 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)

  • B0521 Exp 8/21/13

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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