The Recall Desk
ModerateFDA (Drugs)·D-787-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Trimix Due to Sterility Concerns

Olympia Pharmacy is recalling 24 units of compounded Trimix nationwide and in Puerto Rico due to FDA inspection findings regarding quality control and sterility assurance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving quality control concerns without confirmed harm.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling 24 units of compounded Trimix. The product was distributed nationwide and in Puerto Rico. The recall is being conducted due to FDA inspection findings that raised concerns regarding quality control processes and the assurance of sterility.

The recall covers specific lots with expiration dates ranging from June 2013 to September 2013. The source text does not report any illnesses or injuries associated with the use of this product.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to dispose of the medication.

The recalled product

Product
Trimix, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Medication
Hazard
Affected units
24

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 (20)

  • B5015 Exp 8/15/13
  • C50001 Exp 8/28/13
  • B5011 Exp 8/1/13
  • C42215 Exp 6/22/13
  • A5028 Exp 6/2/13
  • B5011 Exp 6/1/13
  • B5020 Exp 6/1/13
  • B50112 Exp 8/11/13
  • C4186 Exp 6/18/13
  • C4158 Exp 6/15/13
  • C4149 Exp 6/14/13
  • C4111 Exp 6/11/13
  • B4124 Exp 8/12/13
  • B4154 Exp 8/15/13
  • B4198 Exp 8/19/13
  • B4226 Exp 8/22/13
  • B4268 Exp 8/22/13
  • C40522 Exp 9/5/13
  • C4118 Exp 9/1/13
  • C4711 Exp 9/7/13

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 concern

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