Vital Care Compounder Recalls Brilliant Blue G Vials Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 14 vials of Brilliant Blue G 0.025% 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in a medical product.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 14 vials of Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV. The product is a prescription (Rx) item manufactured in Hattiesburg, MS. The specific lot number is 396817, with a use-by date of 09/13/16.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microbial contamination.
The affected product was distributed in Mississippi (MS). Consumers and healthcare providers who possess this specific lot of Brilliant Blue G should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Compounded Pharmaceutical
- Hazard
- Affected units
- 14
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# 396817
- 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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