The Recall Desk
HighFDA (Drugs)·D-0903-2022·Announced 2022-06-01

Pharmaceutical Diluent Recalled for Lack of Sterility Assurance

Olympia Compounding Pharmacy is recalling pharmaceutical diluent vials due to lack of sterility assurance. The product was distributed nationwide in 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 pharmaceutical recall with no reported illnesses or injuries in the source material. The hazard (lack of sterility assurance) is preventive in nature, but pharmaceutical sterility is critical for patient safety, and nationwide distribution presents a risk-of-harm scenario without yet-reported injury.

Plain-English summary

Olympia Compounding Pharmacy, located in Orlando, Florida, is recalling Diluent for Reconstitution Multi-Dose 10 mL vials (NDC 73198-0113-10) due to lack of assurance of sterility. A total of 42,722 vials have been recalled.

The pharmaceutical diluent is used in healthcare settings to reconstitute medications for patient use. A lack of sterility assurance in pharmaceutical diluents presents a risk to patients who receive medications reconstituted with these products, as sterile quality is essential for injectable medications and other critical-care pharmaceutical products.

The affected product was distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. The recall involves multiple lot numbers with Beyond-Use Dates ranging from October 2022 through February 2023, including lots J24125, J24025, K24002, L24013, L24213, A24003, A24404, A24031-22, and B24001-22.

Healthcare providers and patients should immediately discontinue use of the recalled product. Questions or reports of adverse events can be directed to Olympia Compounding Pharmacy or the FDA.

The recalled product

Product
Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Pharmaceutical Diluent
Hazard
  • sterility-assurance

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 (9)

  • Lots: J24125
  • J24025 BUD: 10/25/2022
  • K24002 BUD: 11/2/2022
  • L24013
  • L24213 BUD: 12/13/2022
  • A24003 BUD: 1/3/2023
  • A24404 BUD: 1/4/2023
  • A24031-22 BUD: 1/31/2023
  • B24001-22 BUD: 2/1/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category