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Class III: unlikely to cause harmTerminated

Pine Pharmaceuticals Brilliant Blue G for Intraocular Injection 0 Recall

Brilliant Blue G for Intraocular Injection 0

Pine Pharmaceuticals, LLC · Tonawanda, NY

Risk level
Class III
Reported by FDA
Mar 28, 2018
Recall ID
D-0607-2018
Check your lot numberHow we source this data

Summary

Pine Pharmaceuticals recalled Brilliant Blue G for Intraocular Injection 0 starting Mar 5, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0607-2018 on Mar 28, 2018. Reason: Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product. Status: Terminated.

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.

Product description

Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01

Lot numbers, UPCs & expiration codes

Lot#: 18098@1, Exp. 7/16/2018

Where it was sold

NY only

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-0607-2018
Classification
Class III
Status
Terminated
Recall initiated
Mar 5, 2018
FDA report date
Mar 28, 2018
Quantity
136 units
Recall type
Voluntary: Firm initiated
Recalling firm
Pine Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-0607-2018, exactly as published.

Show all FDA fields
City
Tonawanda
State
NY
Status
Terminated
Country
United States
Event ID
79457
Address
100 Colvin Woods Pkwy
Address (line 2)
Ste 300
Code information
Lot#: 18098@1, Exp. 7/16/2018
Postal code
14150-6974
Report date
Mar 28, 2018
Product type
Drugs
Recall number
D-0607-2018
Classification
Class III
Recalling firm
Pine Pharmaceuticals, LLC
Product quantity
136 units
Termination date
Apr 23, 2018
Reason for recall
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01
Distribution pattern
NY only
Recall initiation date
Mar 5, 2018
Initial firm notification
Letter
Center classification date
Mar 26, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0607-2018, published Mar 28, 2018. View the source record (openFDA) · FDA enforcement reports

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

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