CLASS II Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
Papaverine/Phentolamine/PGE-1 Injectable recalled
Liberty Drug & Surgical is recalling Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL vial, distributed in New Jersey, New York. The recall was initiated on 15 Jun 2015 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-1386-2015
- FDA event ID
- 71591
- Recalling firm
- Liberty Drug & Surgical, Chatham, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2015
- FDA classified
- 27 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Jun 2015 | Recall initiated by company | |
| 27 Aug 2015 | Classified by FDA | +73 days |
| 2 Sep 2015 | Published 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 Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
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/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Where it was distributed
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Which lots are affected?
Lot #: 06042015@9, Exp 07/19/15
Where was it sold?
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
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
24 other products · FDA event 71591This product is part of a recall event; the main page for the event is Vancomycin 25 mg/mL Opthalmic Solution recalled.
More recalls from Liberty Drug & Surgical
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Papaverine/Phentolamine/Atropine/PGE-1 Injectable recalled | Liberty Drug & Surgical | Sterility | NJ, NY |
| Drug | CLASS II | Doxycycline/0.9% NaCl 300 mg/ IV recalled by Liberty Drug & Surgical | Liberty Drug & Surgical | Sterility | NJ, NY |
| Drug | CLASS II | Dexamethasone 24 mg/mL Injectable vial recalled | Liberty Drug & Surgical | Sterility | NJ, NY |
| Drug | CLASS II | Tobramycin 14 mg/mL Ophthalmic Solution recalled | Liberty Drug & Surgical | Sterility | NJ, NY |
| Drug | CLASS II | Doxycycline/0.9 % NaCl 100 mg/ IV recalled by Liberty Drug & Surgical | Liberty Drug & Surgical | Sterility | NJ, NY |
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 |