D-0613-2017 Class II Terminated
FDA drug recall D-0613-2017 was initiated by Claris Lifesciences Inc on March 10, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated September 18, 2020). Affected quantity: 18,360 units (765 cartons x 24 bags).
Recall Details
- Product Type
- Drugs
- Report Date
- April 5, 2017
- Initiation Date
- March 10, 2017
- Termination Date
- September 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,360 units (765 cartons x 24 bags)
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot #: A051288, Exp. Sep 2017