FDA Recalls Compounded Papaverine Injection Due to Sterility Assurance
Olympia Compounding Pharmacy is recalling T-105 Papaverine injection vials due to lack of assurance of sterility. The recall affects 3,312 vials distributed nationwide.
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 of an injectable compounded drug with a theoretical sterility hazard and no reported illnesses. Risk-of-harm products without reported injuries are rated High per the severity rubric.
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling T-105 Papaverine 30 mg/mL, Phentolamine 1 mg/mL, and PGE 10 mcg/mL injection due to lack of assurance of sterility. The recall includes 2.5 mL multi-dose vials (NDC 73198-0005-03) and 5 mL multi-dose vials (NDC 73198-0005-05).
The affected lot numbers are K41J09 and K41I09 with a beyond-use date of November 9, 2022, and lot B24B22-22 with a beyond-use date of February 22, 2023. A total of 3,312 vials have been distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.
Patients and healthcare providers with questions about this recall should contact their healthcare provider or the FDA.
The recalled product
- Product
- T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injection
- Hazard
- contamination-risk
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 (3)
- Lots: K41J09
- K41I09 BUD: 11/9/2022
- B24B22-22 BUD: 2/22/2023
Distribution
Distributed nationwide across the United States.
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