Olympia Pharmacy Recalls Compounded Guanabenz Injection Due to Sterility Concerns
Olympia Pharmacy is recalling three vials of compounded Guanabenz 8 mg/ml Injection due to FDA inspection findings regarding 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 source text explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe).
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, Florida, is recalling three vials of Guanabenz 8 mg/ml Injection. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to ensure the sterility of the compounded product.
The affected product was distributed nationwide and in Puerto Rico. The specific lots involved are C3621 (expiration date 9/21/13), L3618 (expiration date 10/31/13), and A0224 (expiration date 6/30/13). The agency has classified this recall as Class II.
Consumers and healthcare providers who possess these specific lots of Guanabenz 8 mg/ml Injection should stop using the product and contact Olympia Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Compounded 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)
- C3621 Exp 9/21/13
- L3618 Exp 10/31/13
- and A0224 Exp 6/30/13
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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