Reported May 4, 2022 · Terminated
Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose…
Olympia Compounding Pharmacy dba Olympia Pharmacy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympia Compounding Pharmacy dba Olympia Pharmacy · 6700 Conroy Rd Ste 155 · Orlando, FL · 32835-3515
Is this the product you have?
- Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.
- Lot codes and dates
- LotsG48C20
- BUD7/20/2022
- G48B20 BUD7/22/2022
- Amount recalled
- 257 vials
This recall covers 34 products
The agency filed one notice per product. You are reading one of them; the other 33 are below.
21 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
This product could cause temporary or reversible health problems — stop using it.
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