Injectable Drug Pentosan Polysulfate Sodium Recalled for Sterility Assurance
Tailor Made Compounding is recalling 220 vials of Pentosan Polysulfate Sodium due to lack of assurance of sterility. The affected batches were distributed nationwide in the United States and Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a manufacturing defect affecting an injectable pharmaceutical product. Lack of sterility assurance in injectable medications represents a risk of contamination and harm, meeting the High severity threshold for risk-of-harm products.
Plain-English summary
Tailor Made Compounding is recalling 220 vials of Pentosan Polysulfate Sodium 250mg/mL due to lack of assurance of sterility. This injectable medication was distributed nationwide in the United States and Puerto Rico.
The recalled product includes three batches: Batch #11292109A2 (expiration 5/28/2022), Batch #01242202A1 (expiration 6/18/2022), and Batch #03022214A1 (expiration 8/29/2022). All affected vials are room-temperature formulations manufactured by TMC Acquisition LLC.
Sterility is essential for injectable products. Lack of assurance of sterility creates a potential risk of contamination.
Patients and healthcare providers who have received these batches should discontinue use and consult their healthcare provider or pharmacist. Affected vials should be returned to the pharmacy or manufacturer.
The recalled product
- Product
- Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug
- Hazard
- Affected units
- 220
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Batch#: 11292109A2
- Exp 5/28/2022
- 01242202A1
- Exp 6/18/2022
- 03022214A1
- Exp 8/29/2022.
Distribution
Part of a larger recall action
This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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