Why it was recalled
Lack of Assurance of Sterility.
Product description
Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lot numbers, UPCs & expiration codes
Lot #: 070717ML, Exp. 1/7/18
Where it was sold
Nationwide within USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1148-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 15, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 10 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bella Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1148-2017, exactly as published.
Show all FDA fields
- City
- Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77959
- Address
- 3101 W Devon Ave
- Code information
- Lot #: 070717ML, Exp. 1/7/18
- Postal code
- 60659-1407
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1148-2017
- Classification
- Class II
- Recalling firm
- Bella Pharmaceuticals, Inc.
- Product quantity
- 10 vials
- Termination date
- Apr 23, 2018
- Reason for recall
- Lack of Assurance of Sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Distribution pattern
- Nationwide within USA
- Recall initiation date
- Aug 15, 2017
- Initial firm notification
- Telephone
- Center classification date
- Sep 12, 2017