The Recall Desk
SevereFDA (Drugs)·D-726-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Enrofloxacin Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Enrofloxacin 20 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.

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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in an injectable medication.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Enrofloxacin 20 mg/ml 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 identified by code A5011 with an expiration date of 11/30/13. The recall covers one unit of the product, which was distributed nationwide and to Puerto Rico.

Consumers and veterinary professionals should stop using the recalled product and contact Olympia Pharmacy or their healthcare provider for further instructions.

The recalled product

Product
Enrofloxacin 20 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)

  • A5011 Exp 11/30/13

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 →