The Recall Desk
SevereFDA (Drugs)·D-781-2013·Announced 2013-07-17

Sodium Salicylate Injection Recalled for Sterility Concerns

Olympia Pharmacy is recalling Sodium Salicylate 40% 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 involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious health consequences.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Sodium Salicylate 40% Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is B5020 with an expiration date of 12/31/13.

The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during compounding. Specifically, the agency identified a lack of assurance of sterility for the product.

Consumers and healthcare providers should stop using the recalled product and contact Olympia Pharmacy for further instructions or a refund.

The recalled product

Product
Sodium Salicylate 40% 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)

  • B5020 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 →

Related recalls

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

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Same hazard · sterility

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