CLASS II Drug recall · Reported 5 Oct 2016 · FDA Enforcement Report

Papaverine 150 mg/Phentolamine 5 mg recalled by Pharmacy Plus

Pharmacy Plus is recalling Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as in a MDV, distributed in Mississippi. The recall was initiated on 26 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: 386606, Use by 8-9-16, 393302, Use by 10-28-16
Quantity recalled386606 - 3 vials, 393302 - 3 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-1535-2016
FDA event ID
75164
Recalling firm
Pharmacy Plus, Hattiesburg, MS
Classification
Class II
Status
Terminated
Recall initiated
26 Jul 2016
FDA classified
27 Sep 2016
Reported
5 Oct 2016
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

26 Jul 2016Recall initiated by company
27 Sep 2016Classified by FDA+63 days
5 Oct 2016Published in enforcement report+8 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

Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402

Where it was distributed

MS

Mississippi

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot#: 386606, Use by 8-9-16, 393302, Use by 10-28-16

Where was it sold?

MS

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

20 other products · FDA event 75164

This product is part of a recall event; the main page for the event is Hyaluronidase, 150 u/ml SDV, Vital Care Compounder recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIHyaluronidase, 150 u/ml SDV, Vital Care Compounder recalledPharmacy PlusSterilityMS
CLASS IIMethylcobalamin 5,000mcg/ml SDV, Rx, Vital Care Compounder recalledPharmacy PlusSterilityMS
CLASS IIHydroxyzine HCl, 50mg/ml Inj MDV, Rx, Vital Care Compounder recalledPharmacy PlusSterilityMS
CLASS IIBuprenorphine, 0.6 mg/ml Injection MDV Sterile, Rx recalledPharmacy PlusSterilityMS
CLASS IIPre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) recalledPharmacy PlusSterilityMS
CLASS IIApomorphine HCl 3mg/ml Sterile Injection Solution, MDV, Rx recalledPharmacy PlusSterilityMS
CLASS IIC-pap/Phen/Prost/Atrop 150/5/5 recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIAutologous Serum Tears, 2 vials, Rx, Vital Care Compounder recalledPharmacy PlusSterilityMS
CLASS IITrypan Blue 0.3% vials, Rx, Vital Care Compounder recalledPharmacy PlusSterilityMS
CLASS IIChlorpheniramine Maleate 10 mg/ml MDV, Rx recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIBrilliant Blue G (BBG) 0.025% SDV, Rx recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIC-pap/Phen/Prost/Atrop 150/7.5 recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIPre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) recalledPharmacy PlusSterilityMS
CLASS IIDMSO 50% with Lidocaine 0.5% SDV, Sterile, Rx recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIMoxi/Dex/Ketorolac 0.5%/0.1%/0.4%, #15 recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIPapaverine 150 mg / Phentolamine 5 mg vials recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIMoxifloxacin 0.5% + Dexamethazone 0.1% vial Contains recalledPharmacy PlusSterilityMS
CLASS IIOlopatadine 0.8% Ophthalmic Solution, Rx recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIMoxifloxacin HCl 1 mg/ml (0.1mg recalled by Pharmacy PlusPharmacy PlusSterilityMS
CLASS IIMorphine Sulfate 15mg/ml Injection MDV, Rx recalled by Pharmacy PlusPharmacy PlusSterilityMS

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