Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
