Compounded pharmaceutical vials recalled due to sterility assurance failure
Olympia Compounding Pharmacy is recalling Lipostat-Plus vials nationwide due to lack of sterility assurance. Approximately 4,843 vials were distributed across the USA, Puerto Rico, and US Virgin Islands.
What this means for you
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: FDA Class II recall for a sterility-critical injectable product with potential for microbial contamination. No illnesses or adverse events are mentioned in the source, and the stated hazard is theoretical.
Plain-English summary
Olympia Compounding Pharmacy is recalling Lipostat-Plus multi-dose vials due to lack of assurance of sterility. Lipostat-Plus is a compounded injectable containing Methionine, Inositol, Choline Chloride, Cyanocobalamin, and Pyridoxine HCL. The FDA has classified this as a Class II recall.
The specific reason for the recall is a lack of assurance of sterility. When sterility cannot be assured for injectable products, there is a potential risk to patients who receive the medication.
Approximately 4,843 vials were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. The affected lots are A24H26-22, A24G26-22 (Best Use Date 7/26/2022), and K24130 (Best Use Date 5/30/2022).
Healthcare providers and patients who have this product should stop use and contact their pharmacy or healthcare provider for guidance regarding replacement or alternatives.
The recalled product
- Product
- Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0047-30.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- sterility-defect
- contamination
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)
- Lots: A24H26-22
- A24G26-22 BUD: 7/26/2022
- K24130 BUD: 5/30/2022
Distribution
Distributed nationwide across the United States.
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