Injectable T-106 Vials Recalled Due to Sterility Assurance Deficiency
Olympia Compounding Pharmacy recalls T-106 injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
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 is an FDA Class II recall with no reported hospitalizations or injuries. The sterility defect is precautionary—manufacturer could not assure sterility—rather than confirmed contamination, placing this at High severity per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Olympia Compounding Pharmacy is recalling T-106, a compounded injectable medication containing Papaverine 30 mg/mL, Phentolamine 1 mg/mL, and Alprostadil 25 mcg/mL. The recalled products are supplied in 5 mL and 10 mL multi-dose vials with lot K24F09 (best-by date 11/9/2022) totaling 3,185 vials.
The FDA classified this as a Class II recall due to lack of assurance of sterility. The manufacturer could not confirm that the medication met sterility requirements during manufacturing. This creates a potential contamination risk for patients receiving the medication.
The affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. Patients and healthcare providers who have this medication in stock should stop using it immediately and contact their pharmacy supplier for instructions on disposal or return. As of this recall, no illnesses or injuries have been reported.
The recalled product
- Product
- T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Multi-Dose vial NDC 73198-0013-10, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 3,185
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 (1)
- Lot: K24F09 BUD: 11/9/2022
Distribution
Part of a larger recall action
This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy 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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