Drug recall: PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.
Bella Pharmaceuticals, Inc. (Chicago, IL) initiated this drug recall on 15 Aug 2017; FDA lists 16 product records under event 77959, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 23 Apr 2018. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Bella Pharmaceuticals, Inc..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bella Pharmaceuticals, Inc., Chicago, IL.
Reason for recall
"Lack of Assurance of Sterility."
Distribution
"Nationwide within USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1146-2017 | PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA. | 82 vials | Class II | Terminated | 20 Sep 2017 |
| D-1147-2017 | Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 30 vials | Class II | Terminated | 20 Sep 2017 |
| D-1148-2017 | Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 10 vials | Class II | Terminated | 20 Sep 2017 |
| D-1149-2017 | G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 3 vials | Class II | Terminated | 20 Sep 2017 |
| D-1150-2017 | Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 5 vials | Class II | Terminated | 20 Sep 2017 |
| D-1151-2017 | B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA. | 45 vials | Class II | Terminated | 20 Sep 2017 |
| D-1152-2017 | Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 7 vials | Class II | Terminated | 20 Sep 2017 |
| D-1153-2017 | Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 5 vials | Class II | Terminated | 20 Sep 2017 |
| D-1154-2017 | L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 5 vials | Class II | Terminated | 20 Sep 2017 |
| D-1155-2017 | MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 5 vials | Class II | Terminated | 20 Sep 2017 |
| D-1156-2017 | Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA. | 6 bottles | Class II | Terminated | 20 Sep 2017 |
| D-1157-2017 | Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 6 bottles | Class II | Terminated | 20 Sep 2017 |
| D-1158-2017 | Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 20 vials | Class II | Terminated | 20 Sep 2017 |
| D-1159-2017 | Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 644 vials | Class II | Terminated | 20 Sep 2017 |
| D-1160-2017 | Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | 2,334 syringes | Class II | Terminated | 20 Sep 2017 |
| D-1161-2017 | BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA. | 200 syringes | Class II | Terminated | 20 Sep 2017 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Apr 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.