Pentosan Polysulfate Sodium 250mg/mL recall: Sterility Concern
Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
Why was Pentosan Polysulfate Sodium 250mg/mL recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Batch#: 11292109A2, Exp 5/28/2022, 01242202A1, Exp 6/18/2022; 03022214A1, Exp 8/29/2022.
- Product
- Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
- Recalling firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Quantity
- 220 vials
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- July 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)