The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0011-2017·Announced 2016-10-19

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.

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 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
Hazard
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.

See all 9 products in this recall →

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