The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-724-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Disodium EDTA Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Disodium EDTA Injection 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for serious health consequences (such as lack of sterility in an injection) are classified as Severe (Score 4), especially given the rule that FDA Class I/II classifications generally map to higher severity scores when significant risks are implied by the defect type.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, FL, is recalling Disodium EDTA Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.

The affected product is Disodium EDTA Injection with code A5616 and an expiration date of 7/31/13. The distribution pattern for this recall is nationwide and 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 FDA has classified this recall as Class II.

The recalled product

Product
Disodium EDTA Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Injection
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)

  • A5616 Exp 7/31/13

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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