Reported May 4, 2022 · Terminated
T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC…
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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 10 ml Multi-Dose vial, NDC 73198-0005-10 |
| 2 | 5 ml Multi-Dose vial, NDC 73198-0005-05 |
| 3 | 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 . |
- Lot codes and dates
- Lotsa)
- D41412 BUD4/22/2022
- E41F10 BUD5/10/2022
- E41G10 BUD5/10/2022
- F24D21 BUD6/21/2022
- b) D41512 BUD4/12/2022
- c) F42B21 BUD6/21/2022
- H42B03 BUD8/3/2022
- H42C03 BUD8/3/2022
- Amount recalled
- 6916 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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