CLASS II Drug recall · Reported 16 May 2018 · FDA Enforcement Report
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL recalled
Vitalab Pharmacy is recalling Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine, distributed nationwide in the US. The recall was initiated on 24 Apr 2018 and the FDA has classified it as Class II.
Check your package
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-0733-2018
- FDA event ID
- 80000
- Recalling firm
- Vitalab Pharmacy, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2018
- FDA classified
- 9 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Apr 2018 | Recall initiated by company | |
| 9 May 2018 | Classified by FDA | +15 days |
| 16 May 2018 | 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: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug 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 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc
Where it was distributed
The recalled product was distributed to patients throughout the United States.
Questions about this recall
Why was it recalled?
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Which lots are affected?
Lot #:T101 03062018@69, 02052018@56, T104 03122018@62, 02072018@95, T105 03122018@63, 02072018@96, T106 03122018@64, 02072018@97, Exp 06/04/2018-06/10/2018
Where was it sold?
The recalled product was distributed to patients throughout the United States.
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
5 other products · FDA event 80000This product is part of a recall event; the main page for the event is Methylcobalamin for injection, 1mg/mL and 10 mg/mL recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Methylcobalamin for injection, 1mg/mL and 10 mg/mL recalled | Vitalab Pharmacy | Sterility | Nationwide | |
| CLASS II | Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL recalled | Vitalab Pharmacy | Sterility | Nationwide | |
| CLASS II | Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin recalled | Vitalab Pharmacy | Sterility | Nationwide | |
| CLASS II | Papaverine 9mg/Phentolamine 1mg/Atropine recalled by Vitalab Pharmacy | Vitalab Pharmacy | Sterility | Nationwide | |
| CLASS II | Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc recalled | Vitalab Pharmacy | Sterility | Nationwide |
More recalls from Vitalab Pharmacy
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc recalled | Vitalab Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Papaverine 9mg/Phentolamine 1mg/Atropine recalled by Vitalab Pharmacy | Vitalab Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin recalled | Vitalab Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL recalled | Vitalab Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin for injection, 1mg/mL and 10 mg/mL recalled | Vitalab Pharmacy | Sterility | Nationwide |
Other Papaverine recalls
All 64| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Papaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Papaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalled | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Papaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalled | Pharmacy Plus | Sterility | 4 states |