The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-773-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Polidocanol Injections Due to Sterility Concerns

Olympia Pharmacy is recalling Polidocanol injections because FDA inspections 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility assurance in an injectable drug corresponds to a 'Severe' severity score (4), as it is not a Class I recall but involves a serious potential risk.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Polidocanol (0.75%, 1%, 3%, and 10%) Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the compounded products.

The affected products were distributed nationwide and in Puerto Rico. Specific lot numbers and expiration dates for the 0.75%, 1%, 3%, and 10% concentrations are identified in the recall documentation. The FDA has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected Polidocanol injections and contact Olympia Pharmacy or their healthcare provider for further instructions on returns or replacements.

The recalled product

Product
Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
6

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 (3)

  • 0.75% Lot L5611 Exp 11/30/13 // 1% Lot b3001 Exp 6/19/13
  • B5014 Exp 8/14/13
  • and A5431 Exp 6/4/13 // 3% Lot A5808 Exp 12/31/13 // 10% Lot C5328 Exp 9/3/13

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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