CLASS II Drug recall · Reported 1 Jun 2022 · FDA Enforcement Report

Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose vial recalled

Olympia Compounding Pharmacy is recalling Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose vial, distributed nationwide in the US. The recall was initiated on 9 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: L41002 BUD: 6/2/2022
Quantity recalled1466 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-0904-2022
FDA event ID
90204
Recalling firm
Olympia Compounding Pharmacy, Orlando, FL
Classification
Class II
Status
Completed
Recall initiated
9 May 2022
FDA classified
25 May 2022
Reported
1 Jun 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

9 May 2022Recall initiated by company
25 May 2022Classified by FDA+16 days
1 Jun 2022Published 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

Lack of assurance of sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30

Where it was distributed

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Lack of assurance of sterility.

Which lots are affected?

Lot: L41002 BUD: 6/2/2022

Where was it sold?

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

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

52 other products · FDA event 90204
ReportedClassRecallCompanyReasonWhere
CLASS IILidocaine 2% (20 mg/mL), Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIT-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil recalledOlympia Compounding PharmacySterilityNationwide
CLASS IISodium Selenite 200 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIQM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIPyridoxine HCL 100 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIMagnesium Chloride, 200 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IINB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIBimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL recalledOlympia Compounding PharmacySterilityNationwide
CLASS IISodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIDiluent for Reconstitution Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIPhenylephrine 1 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIVitamin D3 (50,000 IU/mL)Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIAlpha Lipoic Acid 25 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IICyanocobalamin 2 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIPyridoxine 100 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IILipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIFormula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE recalledOlympia Compounding PharmacySterilityNationwide
CLASS IISB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIMethylcobalamin 5 mg/mL, Packaged as a) Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIDexpanthenol 250 mg/mL Multi-Dose recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIAT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine recalledOlympia Compounding PharmacySterilityNationwide
CLASS IITestosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IITri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIUltratest Testosterone Cypionate 160 mg/mL Testosterone recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIFolic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IILidocaine 1%/Epinephrine 1:, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIFA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIRE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil recalledOlympia Compounding PharmacySterilityNationwide
CLASS IILipostat Plus SF Inositol 50 mg/mL Choline Chloride recalledOlympia Compounding PharmacySterilityNationwide
CLASS IISodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIPreserved Ascorbic Acid 500 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIOndansetron Hydrochloride, 1 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIRE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIMICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIOlympia Vita-Complex Thiamine HCL recalledOlympia Compounding PharmacySterilityNationwide
CLASS IISB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIQM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIPGE-3 Alprostadil 150 mcg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIT-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIFormula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL recalledOlympia Compounding PharmacySterilityNationwide
CLASS IISodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIFormula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL recalledOlympia Compounding PharmacySterilityNationwide
CLASS IICalcium Chloride 10% (100 mg/mL), Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIMyers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIQM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIAmino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIOlympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc recalledOlympia Compounding PharmacySterilityNationwide
CLASS IITestosterone Cypionate 200 mg/mL in Sesame Oil recalledOlympia Compounding PharmacySterilityNationwide
CLASS IINAD+ Nicotinamide Adenine Dinucleotide recalledOlympia Compounding PharmacySterilityNationwide
CLASS IIZinc Chloride (0.5 mg/mL), Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
CLASS IILipo-Mino-Mix Pyridoxine HCL recalled by Olympia Compounding PharmacyOlympia Compounding PharmacySterilityNationwide
CLASS IISermorelin Acetate Lyophilized powder recalledOlympia Compounding PharmacySterilityNationwide

More recalls from Olympia Compounding Pharmacy

All 94
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISermorelin Acetate Lyophilized powder recalledOlympia Compounding PharmacySterilityNationwide
DrugCLASS IILipo-Mino-Mix Pyridoxine HCL recalled by Olympia Compounding PharmacyOlympia Compounding PharmacySterilityNationwide
DrugCLASS IIZinc Chloride (0.5 mg/mL), Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
DrugCLASS IINAD+ Nicotinamide Adenine Dinucleotide recalledOlympia Compounding PharmacySterilityNationwide
DrugCLASS IITestosterone Cypionate 200 mg/mL in Sesame Oil recalledOlympia Compounding PharmacySterilityNationwide