The Recall Desk
HighFDA (Drugs)·D-1054-2016·Announced 2016-07-06

Vital Care Compounder Recalls Methylcobalamin Vials Due to Sterility Concerns

Vital Care Compounder is recalling 39 vials of Methylcobalamin 5,000 mcg/ml because aluminum crimps may not fully seal the rubber stoppers, compromising sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Vital Care Compounder is recalling 39 vials of Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%, 1 mL Single-Dose Vials. The recall is due to a lack of assurance of sterility, as the aluminum crimps do not fully seal the rubber stopper to the vials.

The affected product is identified by Lot # 389279 with a use-by date of 09-09-16. The product was distributed in Mississippi.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
Manufacturer
Vital Care Compounder
Category
Drug — Injectable
Hazard
Affected units
39

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: 389279
  • Use by 09-09-16

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Vital Care Compounder

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Same hazard · sterility failure

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