FDAFDA · Food and drugs·Recall number D-1221-2022
Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
Published July 20, 2022 · Recall initiated: March 7, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Batch#: 11292109A2, Exp 5/28/2022, 01242202A1, Exp 6/18/2022; 03022214A1, Exp 8/29/2022.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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