FDAClass IIJune 1, 2022

Diluent for Reconstitution Multi-Dose recall: Sterility Concern

Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10

Why was Diluent for Reconstitution Multi-Dose recalled?

Lack of assurance of sterility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Quantity
42,722 vials
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Recall date
June 1, 2022
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls