Vital Care Compounder Recalls Trypan Blue Vials Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 62 vials of Trypan Blue 0.3% due to a lack of assurance of 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a structural or sterility defect in a medical product is categorized as Severe (Score 4), particularly given the risk of infection associated with non-sterile injectable compounds.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder, located in Hattiesburg, Mississippi, is recalling 62 vials of Trypan Blue 0.3%, 0.5ml. The recall is being conducted due to a lack of assurance of sterility in the product.
The affected product is identified by Lot # 396770 with a use-by date of 09-13-16. The recall is limited to distribution within Mississippi. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers who have purchased or possess this product should stop using it and contact the recalling firm or their healthcare provider for further instructions on disposal or return.
The recalled product
- Product
- Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Affected units
- 62
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# 396770
- Use by 09-13-16
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 21 recalled by Pharmacy Plus, Inc. dba 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.
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