D-1221-2022 Class II Ongoing

Recalled by TMC Acquisition LLC dba Tailor Made Compounding — Nicholasville, KY

Recall Details

Product Type
Drugs
Report Date
July 20, 2022
Initiation Date
March 7, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
220 vials

Product Description

Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Batch#: 11292109A2, Exp 5/28/2022, 01242202A1, Exp 6/18/2022; 03022214A1, Exp 8/29/2022.