The Recall Desk
SevereFDA (Drugs)·D-740-2013·Announced 2013-07-17

FDA Recalls Compounded HCG Injections Due to Sterility Concerns

Olympia Pharmacy is recalling compounded HCG injections because FDA inspections 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. According to the severity rubric, an FDA Class II recall with potential for adverse health consequences (such as sterility issues in injectable drugs) corresponds to a score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High risk due to the nature of the defect in a medical product.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for compounded Human Chorionic Gonadotropin (HCG) injections manufactured by Lowlite Investments, Inc. D/B/A Olympia Pharmacy in Orlando, Florida. The affected products include HCG 125iu/0.25ml (550iu/ml), 3500iu, and 10,000iu formulations. Specific lot numbers and expiration dates are: 500iu Lot A3504 (Exp 8/31/13), 3500iu Lot C3105 (Exp 9/5/13), and 10000 iu Lot C3611 (Exp 9/6/13).

The recall was initiated due to FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the products. The agency classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The products were distributed nationwide and in Puerto Rico. Consumers who have purchased these specific lots of HCG injections should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Compounded Biologic
Hazard
Affected units
3

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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