Home / Recalls / TMC Acquisition LLC dba Tailor Made Compounding / D-1221-2022

D-1221-2022 Class II Ongoing

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

FDA drug recall D-1221-2022 was initiated by TMC Acquisition LLC dba Tailor Made Compounding on March 7, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 220 vials.

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.

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D-1216-2022 Class II — Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor (March 7, 2022)