QM-4 Compounded Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls QM-4, a multi-drug compounded injectable, due to lack of assured sterility. 914 vials distributed nationwide in the USA, Puerto Rico, and US Virgin Islands are affected.
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 for a sterile compounded injectable with confirmed lack of sterility assurance. The hazard is theoretical with no reported illnesses or injuries, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy has recalled QM-4, a multi-drug compounded injectable containing Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 300 mcg/mL, and Atropine 0.2 mg/mL in multi-dose 10 mL vials. The recall is due to lack of assurance of sterility.
The affected lot is L24F08 with a beyond-use date of 12/8/2022. A total of 914 vials have been distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Patients and healthcare providers who have received this product should discontinue use and consult with their healthcare provider or contact the manufacturer for instructions regarding the recalled vials. No illnesses or injuries have been reported in the source documentation.
The recalled product
- Product
- QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0020-10
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance-failure
- 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 (1)
- Lot: L24F08 BUD: 12/8/2022
Distribution
Distributed nationwide across the United States.
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