Drug product
17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
D-1391-2015
Product summary
- Event
- Event 71591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 vials
- Official record key
drug-enforcement:D-1391-2015
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 #: 03182015@8, Exp 07/31/15; 05112015@7, Exp 09/24/15
Distribution pattern: Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility