FDAClass IISeptember 2, 2015

Papaverine/Phentolamine/PGE-1 Injectable recall: Sterility Concern

Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham…

Why was Papaverine/Phentolamine/PGE-1 Injectable 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 05112015@19, Exp 06/25/15

Product
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham…
Recalling firm
Liberty Drug & Surgical
Quantity
2 vials
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Recall date
September 2, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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