The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-779-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Sermorelin/GHRP Vials Due to Sterility Concerns

Olympia Pharmacy is recalling Sermorelin/GHRP vials because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

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 involving significant risks such as sterility issues in compounded drugs are categorized as Severe (Score 4), particularly when specific injury reports are not explicitly detailed but the defect is structural to the drug's safety.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Sermorelin/GHRP 3 mg/3 mg vials. The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.

The affected product is identified by code A5811 with an expiration date of 11/30/13. The vials were distributed nationwide and in Puerto Rico.

Consumers who have this product should stop using it and contact Olympia Pharmacy for further instructions or a refund.

The recalled product

Product
Sermorelin/GHRP 3 mg/3 mg vial, 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)

  • A5811 Exp 11/30/13

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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