Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Olympia Compounding Pharmacy recalled 1,710 vials of RE-2 injectable medication due to lack of assurance of sterility. 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: FDA Class II injectable medication recall with no reported illnesses or hospitalizations. Meets rubric criterion for High severity: risk-of-harm product (injectable medication) where injury has not yet been reported. Sterility is a critical attribute for injectables.
Plain-English summary
Olympia Compounding Pharmacy is recalling RE-2 injectable medication containing Papaverine 30 mg/mL, Phentolamine 3 mg/mL, and Alprostadil 300 mcg/mL due to lack of assurance of sterility. The recall affects 1,710 vials (NDC 73198-0016-03 and NDC 73198-0016-10, lots K24B09 and K24C09).
The affected medication was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. Lack of assurance of sterility is a serious concern for injectable medications, as non-sterile products intended for injection can lead to bacterial or fungal infection at the injection site and systemically.
Healthcare providers should immediately stop using affected lots and contact patients who may have received injections from these vials. Patients who received this medication should consult their healthcare provider to discuss any concerns or symptoms.
The recalled product
- Product
- RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility
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 (2)
- Lots: K24B09
- K24C09 BUD: 11/09/2022
Distribution
Distributed nationwide across the United States.
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