CLASS III Drug recall · Reported 30 Mar 2022 · FDA Enforcement Report
Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL recalled
Olympia Compounding Pharmacy is recalling Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01, distributed nationwide in the US. The recall was initiated on 8 Mar 2022 and the FDA has classified it as Class III.
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-0720-2022
- FDA event ID
- 89717
- Recalling firm
- Olympia Compounding Pharmacy, Orlando, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Mar 2022
- FDA classified
- 29 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Undeclared Sulfites
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Mar 2022 | Recall initiated by company | |
| 29 Mar 2022 | Classified by FDA | +21 days |
| 30 Mar 2022 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub Potent
Product as listed by the FDA
Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10
Where it was distributed
Nationwide in the USA including Puerto Rico.
Questions about this recall
Why was it recalled?
Sub Potent
Which lots are affected?
Lot: D41C19 Exp. 4/19/22
Where was it sold?
Nationwide in the USA including Puerto Rico.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
6 other products · FDA event 89717This product is part of a recall event; the main page for the event is Sermorelin Acetate Lyophilized powder for reconstitution recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sermorelin Acetate Lyophilized powder for reconstitution recalled | Olympia Compounding Pharmacy | Other | Nationwide | |
| CLASS III | Hydroxocobalamin B12 1mg/mL, Multi-Dose vial recalled | Olympia Compounding Pharmacy | Other | Nationwide | |
| CLASS II | Sincalide Lyophilized powder recalled by Olympia Compounding Pharmacy | Olympia Compounding Pharmacy | Other | Nationwide | |
| CLASS III | T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE recalled | Olympia Compounding Pharmacy | Undeclared Sulfites | Nationwide | |
| CLASS III | SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL recalled | Olympia Compounding Pharmacy | Undeclared Sulfites | Nationwide | |
| CLASS II | NAD+ Nicotinamide Adenine Dinucleotide recalled | Olympia Compounding Pharmacy | Other | Nationwide |
More recalls from Olympia Compounding Pharmacy
All 94| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sermorelin Acetate Lyophilized powder recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Lipo-Mino-Mix Pyridoxine HCL recalled by Olympia Compounding Pharmacy | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Zinc Chloride (0.5 mg/mL), Multi-Dose vial recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | NAD+ Nicotinamide Adenine Dinucleotide recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate 200 mg/mL in Sesame Oil recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
Other Formula F9 recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . recalled | Olympia Compounding Pharmacy | Manufacturing (CGMP) Deviations | Nationwide |