CLASS II Drug recall · Reported 4 May 2022 · FDA Enforcement Report
Formula F9, Papaverine 9mg/ml . Phentolamine 1mg/ml . PGE recalled
Olympia Compounding Pharmacy is recalling Formula F9, Papaverine 9mg/ml . Phentolamine 1mg/ml . PGE 20mcg/mL Atropine 01mg/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
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.
Recall details
- Recall number
- D-0800-2022
- FDA event ID
- 89938
- Recalling firm
- Olympia Compounding Pharmacy, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Apr 2022
- FDA classified
- 27 Apr 2022
- Reported
- 4 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Apr 2022 | Recall initiated by company | |
| 27 Apr 2022 | Classified by FDA | +23 days |
| 4 May 2022 | Published in enforcement report | +7 days |
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
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. NDC: 73198-0004-10
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Formula F9, Papaverine 9mg/ml . Phentolamine 1mg/ml . PGE 20mcg/mL Atropine 01mg/ml recalled?
Yes. Olympia Compounding Pharmacy recalled Formula F9, Papaverine 9mg/ml . Phentolamine 1mg/ml . PGE 20mcg/mL Atropine 01mg/ml on 4 Apr 2022. The recall is Class II and its status is Terminated. Recall number D-0800-2022.
Why was it recalled?
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: D41C19 BUD: 4/19/2022, I42C13 BUD: 9/13/2022, I42B13 BUD: 9/13/2022
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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