The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-734-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Gentamicin 80 mg/ml Injection because FDA inspections 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported here, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of harm (sepsis/infection) that aligns with the Severe tier for high-risk pathogens or significant injury potential in the absence of Class I classification.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one lot of Gentamicin 80 mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is L3419 with an expiration date of 9/30/13.

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 agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Gentamicin 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — 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)

  • L3419 Exp 9/30/13

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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