Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling QM-2, a compounded multi-dose injectable medication, because the manufacturer cannot assure the product's sterility. The recall affects 619 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 a sterile injectable product with lack of assurance of sterility. No illnesses or injuries have been reported. The hazard is significant but unconfirmed, warranting a High severity rating.
Plain-English summary
Olympia Compounding Pharmacy is recalling QM-2, a prescription compounded multi-dose injectable medication. The product contains papaverine, phentolamine, alprostadil, and atropine. The recall was initiated because the manufacturer could not assure the product's sterility.
Approximately 619 vials of QM-2 with Lot K24D15 and a beyond-use date of November 15, 2022, were distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.
Patients should not use this product and should contact their healthcare provider or pharmacy for information about alternative medications.
The recalled product
- Product
- QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility
- contamination
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: K24D15 BUD: 11/15/2022
Distribution
Distributed nationwide across the United States.
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