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.
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, 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
- 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.
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