D-1384-2015 Class II Terminated

Recalled by Liberty Drug & Surgical — Chatham, NJ

Recall Details

Product Type
Drugs
Report Date
September 2, 2015
Initiation Date
June 15, 2015
Termination Date
April 23, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 vials

Product Description

Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

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.

Distribution Pattern

Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

Code Information

Lot #: 05282015@7, Exp 07/13/15