Agency classClass IIOur severity:High FDA (Drugs)·D-0937-2022·Announced 2022-06-01

MICC Injectable Drug Recalled for Lack of Sterility Assurance

Olympia Compounding Pharmacy is recalling 5,334 vials of MICC injectable due to lack of sterility assurance. Distribution was 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: FDA Class II recall for a compounded injectable drug with lack of sterility assurance. No illnesses or adverse events have been reported, but the hazard is high-risk—contamination of injectable solutions poses serious infection risk. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

MICC (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline Chloride 50 mg/mL, Cyanobalamin 330 mcg/mL) is a compounded injectable solution manufactured by Olympia Compounding Pharmacy and distributed in 10 mL and 30 mL multi-dose vials. A total of 5,334 vials with lot numbers K41F17, K41B17, K41C17, and K41E17 are subject to this recall.

The recall was issued because Olympia Compounding Pharmacy cannot assure that the product meets sterility requirements. Lack of sterility assurance for injectable solutions poses a risk of infection to patients who receive injections from affected vials.

The affected vials were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. Patients who may have received medication from affected vials should contact their healthcare provider for guidance.

If you have any of the recalled vials, do not use them. Consult your healthcare provider about appropriate treatment alternatives and verify the lot number of any MICC product you have in your possession.

The recalled product

Product: MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Compounded Injectable
Hazard: sterility
infection-risk
Affected units: 5,334

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 (4)

Lots: K41F17
K41B17
K41C17
K41E17 BUD: 5/17/2022

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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