CLASS II Drug recall · Reported 25 Jun 2014 · FDA Enforcement Report

Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg recalled

John W Hollis is recalling Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, John Hollis, distributed nationwide in the US. The recall was initiated on 12 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 2187, best used by 05/26/14

Quantity recalled10 mL

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-1401-2014
FDA event ID: 68557
Recalling firm: John W Hollis, Nashville, TN
Classification: Class II
Status: Terminated
Recall initiated: 12 May 2014
FDA classified: 18 Jun 2014
Reported: 25 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility

Timeline

12 May 2014	Recall initiated by company
18 Jun 2014	Classified by FDA	+37 days
25 Jun 2014	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

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

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 HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Which lots are affected?

Lot: 2187, best used by 05/26/14

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

18 other products · FDA event 68557

This product is part of a recall event; the main page for the event is Polidocanol 1% Solution for Injection recalled by John W Hollis.

Reported	Class	Recall	Company	Reason	Where
25 Jun 2014	CLASS II	Polidocanol 1% Solution for Injection recalled by John W Hollis	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Polidocanol 0.5% Solution for Injection, Polidocanol recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Mannitol 5% Solution for injection, Mannitol 50 mg recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Levocarnitine Solution for injection, l-Carnitine 50 mg recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Pyridoxine HCL, Pyridoxine HCl 100mg, Also Contans recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Liver Derivative Complex for injection, each mL contains recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Lipotropic Gold, Each mL contains: Levocarnitine 5 mg recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Polidocanol 5% Solution for Injection recalled by John W Hollis	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Methylcobalamin For Intramuscular OR Subcutaneous Use Only recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Testosterone Cypionate for Injection recalled by John W Hollis	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) and b) recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	MIC PLUS B12, Adenosine, L-Carnitine, Contains recalled by John W Hollis	John W Hollis	Sterility	Nationwide
25 Jun 2014	CLASS II	Cyanocobalamin For Intramuscular OR Subcutaneous Use Only recalled	John W Hollis	Sterility	Nationwide

More recalls from John W Hollis

All 23

Reported	Class	Recall	Company	Reason	Where
25 Jun 2014Drug	CLASS II	Cyanocobalamin For Intramuscular OR Subcutaneous Use Only recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014Drug	CLASS II	MIC PLUS B12, Adenosine, L-Carnitine, Contains recalled by John W Hollis	John W Hollis	Sterility	Nationwide
25 Jun 2014Drug	CLASS II	Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) and b) recalled	John W Hollis	Sterility	Nationwide
25 Jun 2014Drug	CLASS II	Testosterone Cypionate for Injection recalled by John W Hollis	John W Hollis	Sterility	Nationwide
25 Jun 2014Drug	CLASS II	Methylcobalamin For Intramuscular OR Subcutaneous Use Only recalled	John W Hollis	Sterility	Nationwide

Other Papaverine recalls

All 64

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS I	Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride	American Regent	Particulate Matter	Nationwide
1 Feb 2023Drug	CLASS II	Papaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalled	Pharmacy Innovations	Sterility	Nationwide
9 Nov 2022Drug	CLASS II	Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus	Pharmacy Plus	Sterility	4 states
9 Nov 2022Drug	CLASS II	Papaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalled	Pharmacy Plus	Sterility	4 states
9 Nov 2022Drug	CLASS II	Papaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalled	Pharmacy Plus	Sterility	4 states