The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-697-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Amikacin Sulfate Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Amikacin Sulfate 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of 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, which corresponds to a 'Severe' rating under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two lots of Amikacin Sulfate 250 mg/ml Injection. The affected lots are identified by codes B5501 (expiration date 8/5/13) and B3025 (expiration date 12/31/13). The product was distributed nationwide and to Puerto Rico.

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 compounded medication.

Consumers and healthcare providers should discontinue use of the recalled lots and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Antibiotic Injection
Hazard
Affected units
2

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)

  • B5501 Exp 8/5/13 and B3025 Exp 12/31/13

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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