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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Vital Care Compounder
- Category
- Drug — Pharmaceutical Compounds
- Hazard
- 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 →Related recalls
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