The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-728-2013·Announced 2013-07-17

FDA Recalls Compounded Estradiol and Testosterone Injection Due to Sterility Concerns

Olympia Pharmacy is recalling compounded Estradiol Cypionate and Test Cyp injections 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. According to the rubric, FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm (infection), aligning with the 'Severe' criteria for significant risk products where the agency classification is Class II.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, FL, and distributed nationwide and to Puerto Rico. The specific code for the affected product is C51212 with an expiration date of 8/12/13.

The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes. Specifically, the agency identified a lack of assurance of sterility for the product. This is classified as an FDA Class II recall.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The recall is limited to the specific lot identified in the source text.

The recalled product

Product
Estradiol Cypionate 2 mg/ml Test Cyp 50 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)

  • C51212 Exp 8/12/13

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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