Reported Mar 28, 2018 · Terminated

Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy…

Pine Pharmaceuticals, LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pine Pharmaceuticals, LLC · 100 Colvin Woods Pkwy · Tonawanda, NY · 14150-6974

Is this the product you have?

  • Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25
  • mg/mL Compounded byPine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01
Lot codes and dates
    • Lot#: 18098@1
    • Exp. 7/16/2018
Amount recalled
136 units

Where it was sold

Why it was recalled

Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 23, 2018 · Data as of Sep 19, 7:15 PM UTC

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