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Class II: temporary or reversible health riskTerminated

Leiter's Compounding Brilliant Blue G 0 Recall

Brilliant Blue G 0

Leiter's Compounding · San Jose, CA

Risk level
Class II
Reported by FDA
Oct 19, 2016
Recall ID
D-0011-2017
Check your lot numberHow we source this data

Summary

Leiter's Compounding recalled Brilliant Blue G 0 starting Sep 20, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0011-2017 on Oct 19, 2016. Reason: Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Product description

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

Lot numbers, UPCs & expiration codes

All unexpired lots; Expirations dates of .09/20/2016 to 10/10/2016

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0011-2017
Classification
Class II
Status
Terminated
Recall initiated
Sep 20, 2016
FDA report date
Oct 19, 2016
Quantity
76,315 total units, all products
Recall type
Voluntary: Firm initiated
Recalling firm
Leiter's Compounding

Original FDA data

Every field from FDA enforcement report D-0011-2017, exactly as published.

Show all FDA fields
City
San Jose
State
CA
Status
Terminated
Country
United States
Event ID
75230
Address
17 Great Oaks Blvd
Code information
All unexpired lots; Expirations dates of .09/20/2016 to 10/10/2016
Postal code
95119-1359
Report date
Oct 19, 2016
Product type
Drugs
Recall number
D-0011-2017
Classification
Class II
Recalling firm
Leiter's Compounding
Product quantity
76,315 total units, all products
Termination date
May 3, 2017
Reason for recall
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide
Recall initiation date
Sep 20, 2016
Initial firm notification
Letter
Center classification date
Oct 12, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0011-2017, published Oct 19, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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