Leiter's Compounding Recalls Brilliant Blue G Injection Due to Sterility Concerns
Leiter's Compounding is recalling Brilliant Blue G injections because they were produced using recalled filters, raising concerns about sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While specific injury reports are not detailed in the text, the lack of sterility assurance in an injectable drug is a significant hazard that aligns with the Severe rating for Class II recalls with potential for serious harm.
Plain-English summary
Leiter's Compounding, located in San Jose, California, is recalling Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free). The recall involves 76,315 total units distributed nationwide. The affected products have expiration dates ranging from 09/20/2016 to 10/10/2016.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that all compounded products within the expiry period were produced using recalled filters. This defect raises the potential risk of contamination in the sterile injectable medication.
Consumers and healthcare providers should stop using the affected Brilliant Blue G injections and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
- Manufacturer
- Leiter's Compounding
- Category
- Drug — Injectable Medication
- Affected units
- 76,315
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)
- All unexpired lots
- Expirations dates of .09/20/2016 to 10/10/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Leiter's Compounding 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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