Injectable pharmaceutical vial recalled due to sterility assurance failure
Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and 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 a risk-of-harm product (injectable medication) where sterility assurance is critical to patient safety. While classified as FDA Class II with no reported illnesses or confirmed contamination, the potential for serious infection from use of non-sterile injectables warrants a High severity rating.
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling NB-343, a multi-dose 10 mL injectable vial containing papaverine 30 mg/mL, phentolamine 3 mg/mL, and PGE 30 mcg/mL (NDC 73198-0010-10). The recall is due to lack of assurance of sterility.
This product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. The affected lot is L24C08 with a beyond-use date of December 8, 2022.
Healthcare providers and patients who have received this product should not use remaining stock and should contact their healthcare provider for guidance regarding any doses that may have been administered.
The recalled product
- Product
- NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0010-10.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable Medication
- Hazard
- sterility-assurance
- contamination-risk
- infection-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 (1)
- Lot: L24C08 BUD: 12/8/2022
Distribution
Distributed nationwide across the United States.
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