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

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Lack of Sterility
Company Name:
Bella Pharmaceuticals, Inc.
Brand Name:
Brand Name(s)
Bella Pharma
Product Description:
Product Description
All lots of unexpired sterile drug products

Company 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.


Company Contact Information

Consumers:
877-235-5279
Media:
Michael Younan
(877) 235 5279

Product Photos