The Recall Desk
ModerateFDA (Drugs)·D-1056-2016·Announced 2016-07-06

Vital Care Compounder Recalls Trypan Blue Vials Due to Sterility Concerns

Vital Care Compounder is recalling 54 vials of Trypan Blue 0.3% because aluminum crimps may not fully seal the rubber stopper, compromising sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving potential but unreported harm.

Plain-English summary

Vital Care Compounder is recalling 54 vials of Trypan Blue 0.3%, 0.5 mL Vial. The recall was initiated because the aluminum crimps on the vials do not fully seal the rubber stopper, which creates a lack of assurance of sterility.

The affected product is identified by Lot #391462 and has a use-by date of 10-06-2016. The distribution was limited to Mississippi (MS).

Consumers and healthcare providers should stop using the affected vials and contact Vital Care Compounder for further instructions or a refund.

The recalled product

Product
Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS
Affected units
54

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#: 391462
  • Use by 10-06-2016

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 →

Same manufacturer · Vital Care Compounder

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