Reported May 4, 2022 · Terminated
Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx…
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 F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835
- NDC73198-0004-10
- Lot codes and dates
- LotsD41C19
- BUD4/19/2022
- I42C13 BUD9/13/2022
- I42B13 BUD9/13/2022
- Amount recalled
- 800 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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