CLASS II ONGOING Drug recall · Reported 9 Nov 2022 · FDA Enforcement Report

Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus

Pharmacy Plus is recalling Papaverine / Phentolamine / Prostaglandin Inj 150MG/10MG/100MCG/ Bottle Solution vial, distributed in Alabama, Louisiana, Mississippi, Tennessee. The recall was initiated on 7 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 66576, BUD: 11/09/2022
Quantity recalled1 vial

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-0043-2023
FDA event ID
90982
Recalling firm
Pharmacy Plus, Hattiesburg, MS
Classification
Class II
Status
Ongoing
Recall initiated
7 Oct 2022
FDA classified
2 Nov 2022
Reported
9 Nov 2022
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

7 Oct 2022Recall initiated by company
2 Nov 2022Classified by FDA+26 days
9 Nov 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: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

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

PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Where it was distributed

AL, LA, MS, and TN

AlabamaLouisianaMississippiTennessee

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Which lots are affected?

Lot: 66576, BUD: 11/09/2022

Where was it sold?

AL, LA, MS, and TN

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

31 other products · FDA event 90982

This product is part of a recall event; the main page for the event is Medroxyprogesterone Acetate 300 MG/ML Suspension vial recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedroxyprogesterone Acetate 300 MG/ML Suspension vial recalledPharmacy PlusSterility4 states
CLASS IIMoxifloxacin Preservative Free Syr, 0.15 mg recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIPapaverine HCL Stock Solution 30MG/ML Solution vial recalledPharmacy PlusSterility4 states
CLASS IIGlycerin Ophthalmic Drops 98.5% Solution droptainer recalledPharmacy PlusSterility4 states
CLASS IIAcetylcysteine Opth 10% Solution droptainers recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IITalc, Sterile Powder, 5 GM vial recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIPapaverine / Phentolamine Injection 150MG / 5MG / Vial recalledPharmacy PlusSterility4 states
CLASS IIPhentolamine 10MG/ML Injection, 10MG/ML Solution vial recalledPharmacy PlusSterility4 states
CLASS IILaureth-9 INJ 2% Solution vial recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIPapaverine/Phentolamine/Prostaglandin Inj recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIPred Acetate / Gatifloxacin 1% / 0.5% Susp droptainers recalledPharmacy PlusSterility4 states
CLASS IICefuroxime Intravitreal Syr 1MG/ Solution in syringe recalledPharmacy PlusSterility4 states
CLASS IIMethylcobalamin PF Injection Solution 5,000 MCG/ML Solution vials recalledPharmacy PlusSterility4 states
CLASS IISerum Tears IN Nsal 20% Opth Solution droptainers recalledPharmacy PlusSterility4 states
CLASS IIPapaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIPapaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalledPharmacy PlusSterility4 states
CLASS IIVoriconazole Opth Solution 2% Sterile Soln droptainer recalledPharmacy PlusSterility4 states
CLASS IIPap/Phen/Prostag/Atropine Inj 150MG/7.5MG/75MCG/1MG bottle recalledPharmacy PlusSterility4 states
CLASS IISemaglutide Injection 5MG/ML (0.25MG/ Soln recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IICeftazidime Intravitreal 2.25MG/ Solution syringe recalledPharmacy PlusSterility4 states
CLASS IIBrilliant Blue G, 0.04% Solution vials recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIAcetylcysteine Opth 5% Solution droptainers recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIVancomycin Intravitreal 1MG/ Solution syringes recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIPapaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalledPharmacy PlusSterility4 states
CLASS IILidocaine Epinephrine Buffered 2%/1:1000 Solution syringe recalledPharmacy PlusSterility4 states
CLASS IIAutologus Tears Serum Soln Full Strength droptainers recalledPharmacy PlusSterility4 states
CLASS IIPapaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IIProstaglandin E1 Injection Solution 500MCG/ML Solution vials recalledPharmacy PlusSterility4 states
CLASS IICyclosporin 0.07% Opth 0.07% Solution recalled by Pharmacy PlusPharmacy PlusSterility4 states
CLASS IILidocaine/Phenylephrine PF Syr 1%/1.5% Solution syringes recalledPharmacy PlusSterility4 states
CLASS IIMitomycin Injection 0.375 mg/mL Syr, 0.375 mg/mL solution syringe recalledPharmacy PlusSterility4 states

More recalls from Pharmacy Plus

All 54
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIC-Semaglutide 5mg/mL injection vials recalled by Pharmacy PlusPharmacy PlusSterilityMS
DrugCLASS IIMitomycin Injection 0.375 mg/mL Syr, 0.375 mg/mL solution syringe recalledPharmacy PlusSterility4 states
DrugCLASS IILidocaine/Phenylephrine PF Syr 1%/1.5% Solution syringes recalledPharmacy PlusSterility4 states
DrugCLASS IICyclosporin 0.07% Opth 0.07% Solution recalled by Pharmacy PlusPharmacy PlusSterility4 states
DrugCLASS IIProstaglandin E1 Injection Solution 500MCG/ML Solution vials recalledPharmacy PlusSterility4 states

Other Papaverine recalls

All 64
ReportedClassRecallCompanyReasonWhere
DrugCLASS IPapaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine HydrochlorideAmerican RegentParticulate MatterNationwide
DrugCLASS IIPapaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
DrugCLASS IIPapaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy PlusPharmacy PlusSterility4 states
DrugCLASS IIPapaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalledPharmacy PlusSterility4 states
DrugCLASS IIPapaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalledPharmacy PlusSterility4 states