The Recall Desk
SevereFDA (Drugs)·D-776-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Compounded Progesterone Injection Due to Sterility Concerns

Olympia Pharmacy is recalling compounded Progesterone 100 mg/ml in Olive Oil Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or death if contaminated, fitting the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, FL, is recalling one unit of compounded Progesterone 100 mg/ml in Olive Oil Injection. The product was distributed nationwide and to Puerto Rico. The specific lot code is B5007 with an expiration date of 8/7/13.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the lack of assurance of sterility. The agency classified this recall as Class II.

Consumers who possess this specific product should stop using it and contact Olympia Pharmacy or their healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
Progesterone 100 mg/ml in Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded 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)

  • B5007 Exp 8/7/13

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

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