Drug product
Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
D-1390-2015
Product summary
- Event
- Event 71591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58 bags
- Official record key
drug-enforcement:D-1390-2015
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 #: 05142015@21, 05192015@22, 05282015@16, 06022015@18, 06102015@16, 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