D-1161-2017 Class II Terminated
FDA drug recall D-1161-2017 was initiated by Bella Pharmaceuticals, Inc. on August 15, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility. The recall status is terminated (terminated April 23, 2018). Affected quantity: 200 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2017
- Initiation Date
- August 15, 2017
- Termination Date
- April 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 syringes
Product Description
BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
Reason for Recall
Lack of Assurance of Sterility.
Distribution Pattern
Nationwide within USA
Code Information
Lot #: 08152017, Exp. 11/15/17