Drug product
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
D-0613-2017
Product summary
- Event
- Event 76733
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,360 units (765 cartons x 24 bags)
- Official record key
drug-enforcement:D-0613-2017
Official wording
Reason: Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Code information: Lot #: A051288, Exp. Sep 2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility