The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-736-2013·Announced 2013-07-17

FDA Recalls Compounded Glutathione Injection Due to Sterility Concerns

Olympia Pharmacy is recalling compounded Glutathione 200 mg/ml Injection because FDA inspection findings raised concerns about 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 rubric specifies that FDA Class II recalls involving significant risks such as sterility concerns in injectable drugs are rated as Severe (4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Glutathione 200 mg/ml Injection compounded by Olympia Pharmacy in Orlando, Florida. The recall is being conducted by Lowlite Investments, Inc. D/B/A Olympia Pharmacy.

The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and the lack of assurance of sterility. The affected product is identified by code C5110 with an expiration date of 9/11/13.

The product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Glutathione 200 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)

  • C5110 Exp 9/11/13

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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