Compounded Injection Medication Recalled Due to Manufacturing Monitoring Deficiencies
Olympia Compounding Pharmacy recalls 1,679 vials of QM-3 injection medication nationwide due to failures in environmental and personnel monitoring during manufacturing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 classification indicates the agency has determined this is a serious manufacturing violation. The failure to properly investigate environmental and personnel monitoring excursions in a compounding pharmacy represents a risk of product contamination, though no illnesses or injuries have been reported.
Plain-English summary
Olympia Compounding Pharmacy is recalling 1,679 vials of QM-3, a prescription compounded injection medication containing Papaverine, Phentolamine, Alprostadil, and Atropine. The product was distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Prior to October 1, 2021, the facility failed to properly investigate environmental and personnel monitoring excursions that exceeded acceptable limits. These monitoring failures could indicate potential contamination risks in the affected product.
Affected lot numbers are E42B12, E42C12, E42D12, H24B23, H24C23, and H24D23. Patients who have received this medication should consult their healthcare provider immediately. Healthcare providers should discontinue use of affected lots and dispose of them in accordance with applicable laws and regulations.
The recalled product
- Product
- QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0019-10.
- Category
- Drug — Injectable / Compounded
- Affected units
- 1,679
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 (6)
- Lots: E42B12 BUD: 5/12/2022
- E42C12 BUD: 5/12/2022
- E42D12 BUD: 5/12/2022
- H24B23 BUD: 8/23/2022
- H24C23 BUD: 8/23/2022
- H24D23 BUD: 8/23/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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