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.
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 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.
See all 105 products in this recall →Related recalls
Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy
See all →- SevereOlympia Pharmacy Recalls Diclazuril Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- HighOlympia Pharmacy Recalls Metabolase Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls Oxytocin Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls Betamethasone Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls HACC 270.1 Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
Same hazard · sterility concern
See all →- HighSegmental Stem Components for ELEOS Limb Salvage System Recalled
FDA (Devices) · 2025-06-04
- HighMEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns
FDA (Devices) · 2024-10-16
- HighProparacaine Hydrochloride Eye Drops Recalled Due to Temperature Exposure
FDA (Drugs) · 2024-10-02
- HighExactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging
FDA (Devices) · 2024-06-26
- HighPantoprazole Sodium for Injection Recalled Due to Sterility Concern
FDA (Drugs) · 2023-09-20
Similar recalls
- HighFDA Recalls Sodium Tetradecyl Sulfate Injection Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Phenylephrine 1 mg/mL Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighCalcium Chloride Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2022-06-01
- HighPyridoxine Injection Vials Recalled by FDA Due to Sterility Failure
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Olympia Alprostadil 150 mcg/mL Injectable Vials for Sterility Concerns
FDA (Drugs) · 2022-06-01
- HighPyridoxine Injection Vials Recalled Due to Sterility Concerns
FDA (Drugs) · 2022-06-01