Recalls / Class II
Class IID-1148-2017
Product
Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Affected lot / code info
- Lot #: 070717ML, Exp. 1/7/18
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- Bella Pharmaceuticals, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 3101 W Devon Ave, N/A, Chicago, Illinois 60659-1407
Distribution
- Quantity
- 10 vials
- Distribution pattern
- Nationwide within USA
Timeline
- Recall initiated
- 2017-08-15
- FDA classified
- 2017-09-12
- Posted by FDA
- 2017-09-20
- Terminated
- 2018-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1148-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.