Compounding Pharmacy Recalls Injectable Medication Vials for Manufacturing Quality Failures
Olympia Compounding Pharmacy recalls 1,871 multi-dose vials of QM-2 injectable medication due to failure to properly investigate manufacturing monitoring excursions prior to October 2021. No illnesses reported.
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: This is a Class II recall involving CGMP violations at a compounding facility where monitoring excursions were not properly investigated, constituting a risk-of-harm product. No illnesses or injuries have been reported, keeping the score at the maximum permitted for recalls with theoretical hazard and no confirmed injury.
Plain-English summary
Olympia Compounding Pharmacy is recalling approximately 1,871 multi-dose vials of QM-2 injectable medication (containing Papaverine, Phentolamine, Alprostadil, and Atropine) distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) compliance violations. Specifically, prior to October 1, 2021, the facility failed to properly investigate environmental and personnel monitoring excursions that exceeded acceptable limits.
The affected lot codes are D41219 (Best Use Date: April 19, 2022) and I24C13 (Best Use Date: September 13, 2022). No illnesses or injuries have been reported in connection with this recall.
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 vial, Rx Only Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0018-10.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,871
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: D41219 BUD: 4/19/2022
- I24C13 BUD: 9/13/2022
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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