Olympia Pharmacy Recalls Calcium Gluconate Due to Sterility Concerns
Olympia Pharmacy is recalling Calcium Gluconate 23% because FDA inspections 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 source explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant quality control failures like sterility assurance in compounded drugs.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Calcium Gluconate 23% compounded in Orlando, Florida. The product was distributed nationwide and to Puerto Rico. The specific lot code is A5914 with an expiration date of 12/31/13.
The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the lack of assurance of sterility. The agency has classified this recall as Class II.
Consumers who possess this specific product should stop using it and contact Olympia Pharmacy or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Calcium Gluconate 23%, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Compounded Medication
- Affected units
- 1
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 (1)
- A5914 Exp 12/31/13
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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