Agency classClass IIOur severity:High FDA (Drugs)·D-0935-2022·Announced 2022-06-01

Magnesium Chloride injection recalled due to lack of sterility assurance

Olympia Compounding Pharmacy is recalling 1,597 vials of Magnesium Chloride injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and the 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 of an injectable pharmaceutical product due to lack of sterility assurance. No reported illnesses or injuries. The lack of reported harm and theoretical nature of the hazard limits the score to 3 per the rubric.

Plain-English summary

Olympia Compounding Pharmacy is recalling 1,597 vials of Magnesium Chloride injection (200 mg/mL, NDC 73198-0072-30, Lot A24012-22). The product was distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands.

The recall was initiated because the manufacturer cannot provide assurance that the product meets sterility standards required for injectable use. Magnesium Chloride injection is administered intravenously and requires confirmed sterility to ensure patient safety.

Healthcare providers and facilities with this product in inventory should cease use of the affected lot immediately. Any individuals who may have received this product should consult their healthcare provider regarding potential health effects from exposure to a non-sterile injectable product.

The recalled product

Product: Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0072-30.
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable / Parenteral
Hazard: lack-of-sterility
bacterial-contamination
Affected units: 1,597

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: A24012-22 BUD: 7/12/2022

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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