QM-3 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Olympia Compounding Pharmacy dba Olympia Pharmacy
Lot Codes / Batch Numbers
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
Products Sold
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
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2 mg/mL, 10 m due to CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly invest. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026