Olympia Pharmacy Recalls Quadmix Due to Sterility Concerns
Olympia Pharmacy is recalling three lots of Quadmix because FDA inspections 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling three lots of Quadmix, a compounded product manufactured in Orlando, Florida. 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 lots are identified by the following codes and expiration dates: C4526 (Exp 9/4/13), B4125 (Exp 8/12/13), and B5014 (Exp 8/1/13). The product was distributed nationwide and to Puerto Rico.
Consumers who have purchased these specific lots should stop using the product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Quadmix, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Compounded Medication
- 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)
- C4526 Exp 9/4/13
- B4125 exp 8/12/13
- and B5014 exp 8/1/13
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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