The Recall Desk
SevereFDA (Drugs)·D-708-2013·Announced 2013-07-17

Olympia Pharmacy Recalls Buprenorphine Injection Due to Sterility Concerns

Olympia Pharmacy is recalling Buprenorphine 0.3 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Buprenorphine 0.3 mg/ml Injection. The recall was initiated after FDA inspection findings resulted in concerns regarding quality control processes and the lack of assurance of sterility.

The affected product was compounded by Olympia Pharmacy in Orlando, FL. The recall covers three units distributed nationwide and to Puerto Rico. The specific lot codes are B3727 (Exp 12/27/13), C5511 (Exp 9/5/13), and L5312 (Exp 11/30/13).

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Manufacturer
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Category
Drug — 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)

  • B3727 Exp 12/27/13
  • C5511 Exp 9/5/13
  • and L5312 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 →

Related recalls

Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy

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Same hazard · sterility

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