Drug product
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
D-1400-2015
Product summary
- Event
- Event 71591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 vials
- Official record key
drug-enforcement:D-1400-2015
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 #: 04202015@18, Exp 06/04/15; 05192015@16, 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