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Tuesday, August 22, 2017

Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

For Immediate Release

August 18, 2017

Contact

Consumers

877-235-5279

Media

Michael Younan
(877) 235 5279

Announcement

Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance.  The recalled products were distributed to health care facilities nationwide. 
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.
The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. 
 
The following products are being affected by this recall:
 
Lot
Expiration Date   
Product Name                 
Container type    
Units Distributed
070617GL
1/6/18
Glutathione 200mg/ml
30ml Vial
82units
070717MC
1/7/18 
Methylcobalamin 1mg/ml
30ml Vial
30units
070717ML      
1/718
Mannitol 20%
10ml Vial
10units
071217GAC    
1/12/18           
GAC
30ml vial
3 units
071217CC
10/12/18
Calcium chloride 10%
10ml vial
5 units
BPBC3080517
2/5/18
B-Complex
30ml vial
45 units
BPMC30072917 
1/29/18
Methylcobalamin 10mg/ml
30ml vial
7 units
BPMC08517
2/5/18
Magnesium Chloride 200mg
30ml vial
5 units
BPLG08517
2/5/18
L-Glutamine 100mg
30ml vial
5 units 
BPMIC30072917 
1/29/18
MIC 25/50/50
30ml Vial
5 units
BPLG3508717
11/7/17           
Lidocaine Gel 3.5%
15ml dropper
6 units
BPPTC08717
11/17/17
Phenylephrine2.5%/Tropicamide 1%
15ml dropper
6 units
BPSB8408717
11/7/17
Sodium Bicarbonate 8.4%
10ml vial
20 units
BPFS41717
4/1/18
Fluorescein Sodium
5ml vial
644 units
3141201
9/13/17
Avastin (Bevacizumab)
BD 30g ½ and 31g 5/16 syringe
30 units
3146966
 9/20/17
Avastin (Bevacizumab)
BD 30g ½ and 31g 5/16 syringe
310 units
3160608
10/5/17
Avastin (Bevacizumab)
BD 30g ½ and 31g 5/16 syringe
784 units
3146966
 11/1/17
Avastin (Bevacizumab)
BD 30g ½ and 31g 5/16 syringe
646 units
“Bella Pharmaceuticals has a longstanding commitment to quality and safety.  We are voluntarily issuing a recall out of an abundance of caution after several issues were identified during a recent FDA inspection of our facility,” Michael Younan, Chairman and CEO of Bella Pharmaceuticals.  “We regret any impact this recall has on our loyal customers and their patients.”
Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products.  Anyone with product subject to the recall should stop using it and contact the company.  To return medication or request assistance related to this recall, contact Bella Pharmaceuticals at 877-235-5279, Monday through Friday, between 9 a.m. and 5 p.m. CST.
Consumers with questions regarding this recall can contact Bella Pharmaceuticals by 877-235-5279 or e-mail address on Monday through Friday, from 9 a.m. and 5 p.m. CST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
 
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
 
###

Product Photos

  • Bella Pharma Methylcobalamin 10mg Sterile 30ml Vial-Methylcobalamin 10mg/ml Sterile Water Sodium Chloride
  • Bella Pharma Methylcobalamin 10mg Sterile 30ml Vial-Methylcobalamin 1mg/ml Sterile Water Sodium Chloride
  • Bella Pharma B-Complex Sterile 30ml Vial
  • Bella Pharma PF-GLUTATHIONE 200mg Sterile 30ml Vial
  • Bella Pharma Mannitol 20%,10ml STERILE VIAL
  • Bella Pharma G.A.C 25/100/250mg Sterile 30ml Vial
  • Bella Pharma L-Glutamine 100mg Sterile 30ml Vial
  • Bella Pharma Magnesium Chloride 200mg Sterile 30ml Vial
  • Bella Pharma Fluorescein Sodium, 5ml Sterile Injectable Dye
  • Bella Pharma M I C 25/50/50 Sterile 30ml Vial
  • Bella Pharma Lidocaine Gel 3.5%, 15ml Sterile Ophthalmic Jelly
  • Bella Pharma Pheny2.5Tropicamide1, 15ml Sterile Ophthalmic Solution
  • Bella Pharma Sodium Bicarbonate 8.4%, 10ml Sterile Solution
  • Bella Pharma Calcium Chloride, 10ml Sterile Solution
  • Bella Pharma Bevacizumab Prefilled 31g Syringe 1.25mg/0.05ml
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