CLASS II Drug recall · Reported 4 May 2022 · FDA Enforcement Report
SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . recalled
Olympia Compounding Pharmacy is recalling SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL Multi-Dose vial, 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
Lot, batch or date codes Lots: E41C18 BUD: 5/18/2022, E41D18 BUD: 5/18/2022, G42D20 BUD: 7/20/2022, G42B20 BUD: 7/20/2022
Quantity recalled 1740 vials
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-0806-2022
FDA event ID 89938
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
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
SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10.
Where it was distributed
Distributed Nationwide in the USA
Nationwide
Questions about this recall
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: E41C18 BUD: 5/18/2022, E41D18 BUD: 5/18/2022, G42D20 BUD: 7/20/2022, G42B20 BUD: 7/20/2022
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 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 33 other products · FDA event 89938 This product is part of a recall event; the main page for the event is NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . recalled .
Reported Class Recall Company Reason Where 4 May 2022 CLASS II NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II PGE-2, Alprostadil 80 mcg/mL Multi-Dose vial recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II Hydroxocobalamin B12, 1 mg/mL Multi-Dose vial recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II ST-1, Papaverine 30 mg/mL . 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Phentolamine 1 mg/mL . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II Ultratest, Testosterone Cypionate 160 mg/mL recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II PGE-3, Alprostadil 150 mcg/mL Multi-Dose vial recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder recalled Olympia Compounding Pharmacy Other Nationwide 4 May 2022 CLASS II SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II Sermorelin Acetate, Lyophilized powder for reconstitution recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . recalled Olympia Compounding Pharmacy Manufacturing (CGMP) Deviations Nationwide 4 May 2022 CLASS II Bimix-3, Papaverine 30 mg/mL . 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