CLASS II Drug recall · Reported 6 Jul 2016 · FDA Enforcement Report
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9% SDV recalled
Vital Care Compounder is recalling Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9% SDV, Vital Care Compounder, distributed in Mississippi. The recall was initiated on 10 Jun 2015 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-1054-2016
- FDA event ID
- 74539
- Recalling firm
- Vital Care Compounder, Hattiesburg, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2015
- FDA classified
- 28 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Jun 2015 | Recall initiated by company | |
| 28 Jun 2016 | Classified by FDA | +384 days |
| 6 Jul 2016 | 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: Aluminum crimps do not fully seal the rubber stopper to the vials.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
Where it was distributed
MS
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Which lots are affected?
Lot#: 389279, Use by 09-09-16
Where was it sold?
MS
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
2 other products · FDA event 74539This product is part of a recall event; the main page for the event is Trypan Blue 0.3% Vial, Vital Care Compounder, Hattiesburg, MS recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Trypan Blue 0.3% Vial, Vital Care Compounder, Hattiesburg, MS recalled | Vital Care Compounder | Foreign Material | MS | |
| CLASS II | Brilliant Blue G BBG recalled by Vital Care Compounder | Vital Care Compounder | Foreign Material | MS |
More recalls from Vital Care Compounder
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate 200mg/ml Mdv, Vital Care Compounder recalled | Vital Care Compounder | Foreign Material | MS |
| Drug | CLASS II | Brilliant Blue G BBG recalled by Vital Care Compounder | Vital Care Compounder | Foreign Material | MS |
| Drug | CLASS II | Trypan Blue 0.3% Vial, Vital Care Compounder, Hattiesburg, MS recalled | Vital Care Compounder | Foreign Material | MS |
Other Methylcobalamin 5 recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylcobalamin 5,000 mcg/mL Injectable vial recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin 5,000mcg/ml SDV, Rx, Vital Care Compounder recalled | Pharmacy Plus | Sterility | MS |
| Drug | CLASS II | Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial recalled | The Compounding Pharmacy of America | Sterility | Nationwide |