Olympia Compounding Pharmacy is recalling RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, distributed nationwide in the US. The recall was initiated on 4 Apr 2022 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesLots: a) E47B18 BUD: 5/18/2022; b) E47C18 BUD: 5/18/2022, H24G31 BUD: 8/31/2022
Quantity recalled1849 vials
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Product as listed by the FDA
RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Which lots are affected?
Lots: a) E47B18 BUD: 5/18/2022; b) E47C18 BUD: 5/18/2022, H24G31 BUD: 8/31/2022
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.