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.”
(Source: FDA)
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