CLASS II Drug recall · Reported 20 Sep 2017 · FDA Enforcement Report
Methylcobalamin 10mg, (10mg/ml) vials recalled by Bella Pharmaceuticals
Bella Pharmaceuticals is recalling Methylcobalamin 10mg, (10mg/ml) vials, distributed nationwide in the US. The recall was initiated on 15 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1152-2017
- FDA event ID
- 77959
- Recalling firm
- Bella Pharmaceuticals, Chicago, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2017
- FDA classified
- 12 Sep 2017
- Reported
- 20 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Aug 2017 | Recall initiated by company | |
| 12 Sep 2017 | Classified by FDA | +28 days |
| 20 Sep 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Where it was distributed
Nationwide within USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility.
Which lots are affected?
Lot #: BPMC30072917, Exp. 1/29/18
Where was it sold?
Nationwide within USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 77959This product is part of a recall event; the main page for the event is L-Glutamine 100mg vials recalled by Bella Pharmaceuticals.
More recalls from Bella Pharmaceuticals
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcium chloride 10% vials recalled by Bella Pharmaceuticals | Bella Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | G.A.C 25/100/250mg Vials recalled by Bella Pharmaceuticals | Bella Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Magnesium Chloride 200mg, 30m L vials recalled by Bella Pharmaceuticals | Bella Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sodium Bicarbonate 8.4% vials recalled by Bella Pharmaceuticals | Bella Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution recalled | Bella Pharmaceuticals | Sterility | Nationwide |
Other Methylcobalamin recalls
All 70| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylcobalamin Injectable, 10mg/mL, pre-filled syringe recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin 1MG/ML vial) recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin 12.5mg/ML Vial) Injectable Methylcobalamin recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin Injection Solution, 12.5mg/ml recalled | Northern VA Compounders Pllc | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin 1mg/mL, a)-vial, b)-vial, Room Temperature recalled | TMC Acquisition | Sterility | Nationwide |