The Recall Desk
SevereFDA (Drugs)·D-745-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Ketamine Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Ketamine 100 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of the absence of reported injuries in the provided text.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Ketamine 100 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 B3411 with an expiration date of 8/11/13.

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 who possess this specific product should stop using it and contact Olympia Pharmacy or their healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
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)

  • B3411 Exp 8/11/13

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 →