Drug product
Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
D-1394-2015
Product summary
- Event
- Event 71591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112 bags
- Official record key
drug-enforcement:D-1394-2015
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 #: 0513215@12, 05192015@1, 05222015@14, 05222015@15, 05282015@17, 06012015@18, 06022015@19, 06052015@23, Exp 07/06/15
Distribution pattern: Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility