The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-777-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Progesterone Injection Due to Sterility Concerns

Olympia Pharmacy is recalling a specific lot of compounded Progesterone EO 100 mg/ml Injection 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling one lot of compounded Progesterone EO 100 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during the compounding of the product.

The specific product affected is identified by the code L3126 with an expiration date of 12/31/13. The distribution pattern for this recall is listed as nationwide and Puerto Rico. The primary reason for the recall is a lack of assurance of sterility, which is a critical quality attribute for injectable medications.

Consumers and healthcare providers who have this specific lot of Progesterone EO 100 mg/ml Injection should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product. This action is taken to ensure patient safety and to address the identified quality control deficiencies.

The recalled product

Product
Progesterone EO 100 mg/ml 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)

  • L3126 Exp 12/31/13

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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