The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-775-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Praziquantel Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Praziquantel 56.8mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which carries a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Praziquantel 56.8mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida. The recall affects one unit with lot number L3320 and an expiration date of 12/31/13.

The recall was initiated because FDA inspection findings resulted in concerns regarding quality control processes, specifically a lack of assurance of sterility. 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
Praziquantel 56.8mg/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)

  • L3320 Exp 12/31/13

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 →

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