CLASS II Drug recall · Reported 24 Apr 2019 · FDA Enforcement Report

Heparin/Lidocaine 2%-/Sodium Bicarbonate 8.4%-/ Sterile recalled

Anderson Compounding Pharmacy is recalling Heparin/Lidocaine 2%-/Sodium Bicarbonate 8.4%-/ Sterile Water, Anderson Compounding, distributed nationwide in the US. The recall was initiated on 2 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots
Quantity recalled6 syringes

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-1160-2019
FDA event ID
82554
Recalling firm
Anderson Compounding Pharmacy, Bristol, TN
Classification
Class II
Status
Terminated
Recall initiated
2 Apr 2019
FDA classified
18 Apr 2019
Reported
24 Apr 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility
Drug class
Blood Thinners

Timeline

2 Apr 2019Recall initiated by company
18 Apr 2019Classified by FDA+16 days
24 Apr 2019Published in enforcement report+6 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 sterility assurance.

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

Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of sterility assurance.

Which lots are affected?

All Lots

Where was it sold?

Nationwide

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

67 other products · FDA event 82554

This product is part of a recall event; the main page for the event is HCG Injection, Anderson Compounding Pharmacy 310 Bluff City recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIHCG Injection, Anderson Compounding Pharmacy 310 Bluff City recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHeparin/Marcain 0.25%/Sodium Bicarbonate 8.4%-/per recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG 23 Day Vial, Anderson Compounding Pharmacy 310 Bluff recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHeparin/Marcaine 0.25%/Sodium Bicarbonate/Normal Saline recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIVitamin D3 200,000 IU/mL Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIDMSO 50%/Heparin/ Sodium Bicarbonate/ Solu-Cortef 100 mg recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHeparin/ Marcain 0.25%/Sodium Bicarbonate 8.4%-/ Normal recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHeparin 20,000 U/Lidocaine 2%/Sodium Bicarbonate recalledAnderson Compounding PharmacySterilityNationwide
CLASS IISermorelin 0.3 mg/ Vial, Anderson Compounding Pharmacy recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Quad with Atropine 10:30:1:0.15 Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Tri-Mix 20:30:1 Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Tri-Mix 20:25:1 Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IISerum Tears 50% Ophthalmic Drops Dropper recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIAcetylcysteine 10% Ophthalmic Eye Drop droptainer recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIBacitracin 3000U/ Irrigation Syringe recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIMorphine Sulfate 5 mg/ Inhalation Vials recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG 23 Day Injection Extra Strength, vials recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin 40 mcg/mL, Vial recalled by Anderson Compounding PharmacyAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Tri-Mix 2.5:7.5:0.25 Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IISerum Tears 20% Drops Droptainer recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIGentamicin 250 mg/ Irrigation recalled by Anderson Compounding PharmacyAnderson Compounding PharmacySterilityNationwide
CLASS IIMethylcobalamin 3000 mcg/mL Injection Solution Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG 20 Day Injection, Anderson Compounding Pharmacy recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIGentamicin 160 mg/ Sterile Water for Irrigation recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIEstrone 5mg/mL Oil Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIDexamethasone 24 mg/mL Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHeparin 20,000U/Marcaine recalled by Anderson Compounding PharmacyAnderson Compounding PharmacySterilityNationwide
CLASS IIStreptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection recalledAnderson Compounding PharmacySterilityNationwide
CLASS IISermorelin 0.4 mg/ Vial, Anderson Compounding Pharmacy recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG 1,000 U/mL Injection, Vial Anderson Compounding recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIMethionine 15mg/Choline 100mg/ Inositol 50mg recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIGentamicin 240 mg/ Sterile Water for Irrigation Syringe recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIGentamicin 120 mg/ 0.9% Sodium Chloride recalledAnderson Compounding PharmacySterilityNationwide
CLASS IISodium Bicarbonate 8.4% Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG 40 Day Injection Extra Strength, vials recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIEstradiol Cypionate 10 mg/mL Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG 30 Day Vial, Anderson Compounding Pharmacy 310 Bluff recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Tri-Mix 60:30:1 Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIMethylcobalamin 1 mg/mL Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIEDTA 1% Sterile Injection (Preservative Free) recalledAnderson Compounding PharmacySterilityNationwide
CLASS IINeomycin 40 mg/Polymixin B 200,000 Bladder Irrigation recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIAmphotericin B 0.15% Eye Drops Droppers recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIPapaverine 30 mg/mL Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin 60 mcg/mL, Vial recalled by Anderson Compounding PharmacyAnderson Compounding PharmacySterilityNationwide
CLASS IIMethylprednisolone 1% PF Ophthalmic Droppers recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIInterferon 1 Million IU/mL Eye Drops Droptainer recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG/B 12 11,000 mcg Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Tri-Mix 5:15:0.5 Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIVancomycin 125 mg/ Inhalation Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIPapaverine 30 mg/Phentolamine 0.5 mg/mL Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHeparin 10,000 U/Bupivacaine recalled by Anderson Compounding PharmacyAnderson Compounding PharmacySterilityNationwide
CLASS IILidocaine 1%/Dextrose 12.5% (PF) Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIAtropine 0.01% Eye Drops and Dropper recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Tri-Mix 30:30:1 Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IISerum Tears 30% Drops Droptainer recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIPenicillin G Syringe, Anderson Compounding Pharmacy recalledAnderson Compounding PharmacySterilityNationwide
CLASS IITestosterone Cypionate 250 mg/mL Sterile Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Tri-Mix 8.33:22.5:0.833 Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIPolyhexamethylene Biguanide 0.02% Ophthalmic Drops Dropper recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIPhenylephrine 1 mg/mL Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIHCG 20 Day Extra Strength Vial recalled by Anderson Compounding PharmacyAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Quad-Mix 20:30:1:0.15 Injection Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIPhenol 10% Injection Vial, Anderson Compounding Pharmacy recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin Tri-Mix 50:30:1 Vial recalledAnderson Compounding PharmacySterilityNationwide
CLASS IIProstaglandin 20 mcg/mL Vial recalled by Anderson Compounding PharmacyAnderson Compounding PharmacySterilityNationwide

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