Drug product
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
D-1383-2015
Product summary
- Event
- Event 71591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 vials
- Official record key
drug-enforcement:D-1383-2015
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 #: 05192015@17, Exp 07/03/15
Distribution pattern: Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility