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Recall Observatory FDA recall evidence

Drug product

Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

D-1385-2015

June 15, 2015

Class II

Product summary

Firm
Liberty Drug & Surgical
Event
Event 71591
Status
Terminated
Classification
Class II
Quantity
4 vials
Official record key
drug-enforcement:D-1385-2015

Official wording

Reason: 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.

Code information: Lot #: 05112015@3, Exp 06/25/15; 06012015@12, Exp 07/17/15

Distribution pattern: Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility