Cal-Phos 1000 Injection Recalled Due to Sterility Concerns
Olympia Pharmacy is recalling Cal-Phos 1000 Injection 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 text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe).
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Cal-Phos 1000 Injection. The product was compounded by Olympia Pharmacy in Orlando, Florida, and distributed nationwide and to Puerto Rico. The specific lot code is A5211 with an expiration date of 12/31/13.
The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and the lack of assurance of sterility. The agency has classified this as a Class II recall.
Consumers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Injection
- Hazard
- 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)
- A5211 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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