Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceutical...

FDA Recall #D-0908-2022 — Class II — May 9, 2022

Recall #D-0908-2022 Date: May 9, 2022 Classification: Class II Status: Completed

Product Description

Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0102-05

Reason for Recall

Lack of assurance of sterility.

Recalling Firm

Olympia Compounding Pharmacy dba Olympia Pharmacy — Orlando, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

588 vials

Distribution

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Code Information

Lot: L24306 BUD: 6/6/2022

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated