The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-782-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Sodium Tetradecyl Sulfate Injections Due to Sterility Concerns

Olympia Pharmacy is recalling specific lots of compounded Sodium Tetradecyl Sulfate injections due to FDA inspection findings regarding 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are categorized as Severe.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling 10 units of Sodium Tetradecyl Sulfate Injection in concentrations of 0.125%, 1%, 2.5%, 3%, and 4%. The affected products were distributed nationwide and to Puerto Rico.

The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to ensure the sterility of the compounded injections. Specific lot numbers and expiration dates for the affected products are listed in the recall documentation.

Consumers and healthcare providers should stop using the affected lots and contact Olympia Pharmacy or their healthcare provider for further instructions.

The recalled product

Product
Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
10

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 (5)

  • 0.125% Lot B3505 Exp 8/1/13 // 1% Lots C5001 Exp 9/30/13
  • C5406 Exp 9/4/13
  • C5301 Exp 9/30/13
  • B5428 Exp 6/4/13
  • and C5212 Exp 9/21/13 // 4% Lot C5301 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 →

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