The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-701-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Atipamezole Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Atipamezole 10 mg/ml Injection because FDA inspection findings 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility concerns in injectable products which carry a risk of infection.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling three units of Atipamezole 10 mg/ml Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the product.

The affected product is identified by the following lot codes and expiration dates: L3628 (Exp 12/31/13), B5306 (Exp 8/6/13), and C3120 (Exp 9/20/13). The product was distributed nationwide and to Puerto Rico.

Consumers and veterinary professionals who possess this product should stop using it and contact Olympia Pharmacy for instructions on return or disposal. The FDA classifies this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — Veterinary Injectable
Hazard
Affected units
3

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 (3)

  • L3628 Exp 12/31/13
  • B5306 Exp 8/6/13
  • and C3120 Exp 9/20/13

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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