D-1157-2017 Class II Terminated
FDA drug recall D-1157-2017 was initiated by Bella Pharmaceuticals, Inc. on Aug 15, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility. The recall status is terminated (terminated Apr 23, 2018). Affected quantity: 6 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 20, 2017
- Initiation Date
- Aug 15, 2017
- Termination Date
- Apr 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 bottles
Product description
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Reason for recall
Lack of Assurance of Sterility.
Distribution pattern
Nationwide within USA
Code information
Lot #: BPPTC08717, Exp. 11/7/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1157-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026