Agency classClass IIOur severity:High FDA (Drugs)·D-0934-2022·Announced 2022-06-01

Injectable drug recalled for lack of sterility assurance

Olympia Compounding Pharmacy is recalling injectable Lipostat Plus SF vials due to inability to assure sterility. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.

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: Severity 3 (High) applies because this is a risk-of-harm product (injectable medication requiring sterility assurance) where no illness or injury has been reported. The rubric applies Score 3 to risk-of-harm products where injury has not yet been reported; this Class II recall involves a sterility defect that creates potential for serious harm through infection if contamination occurred.

Plain-English summary

Olympia Compounding Pharmacy is recalling Lipostat Plus SF, a multi-dose injectable vial containing inositol, choline chloride, cyanocobalamin, and pyridoxine HCL (NDC 73198-0048-30).

The recall was issued because the manufacturer cannot assure that the product meets sterility standards required for injectable medications. Sterility is critical for injected drugs because the injection process bypasses the body's natural protective barriers, and any microbial contamination could cause serious infection.

Affected vials carry lot number K24030 with a beyond-use date of May 30, 2022. Approximately 1,571 vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.

Healthcare providers and patients who have received or possess this product should contact their healthcare provider and not use remaining vials. Consult a healthcare provider about alternative treatments if you have received an injection of this product.

The recalled product

Product: Lipostat Plus SF 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 73198-0048-30
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable
Hazard: lack-of-sterility
Affected units: 1,571

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)

Lot: K24030 BUD: 5/30/2022

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 53 recalled by Olympia Compounding Pharmacy dba 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 53 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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