Agency classClass IIOur severity:High FDA (Drugs)·D-0916-2022·Announced 2022-06-01

FDA Recalls Zinc Chloride Injectable Due to Sterility Concerns

Olympia Compounding Pharmacy is recalling 1,291 vials of Zinc Chloride injectable nationwide due to lack of assurance of sterility.

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: This FDA Class II drug recall involves lack of sterility assurance in an injectable medication. The recall notice does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not been reported score 3 (High).

Plain-English summary

Olympia Compounding Pharmacy is recalling 1,291 vials of Zinc Chloride (0.5 mg/mL) multi-dose injectable, NDC 73198-0071-30, Lot K24024, with expiration date 5/24/2022. This is a prescription-only drug distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.

The recall was issued due to lack of assurance of sterility. Multi-dose injectables must maintain sterility to prevent contamination and potential infection in patients receiving the medication.

Patients and healthcare providers should discontinue use of affected vials immediately. Contact your healthcare provider or Olympia Compounding Pharmacy if you have received this product.

The recalled product

Product: Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0071-30
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable
Hazard: lack-of-sterility
contamination
Affected units: 1,291

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: K24024 BUD: 5/24/2022

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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