Drug product
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
D-0607-2018
Product summary
- Event
- Event 79457
- Status
- Terminated
- Classification
- Class III
- Quantity
- 136 units
- Official record key
drug-enforcement:D-0607-2018
Official wording
Reason: Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Code information: Lot#: 18098@1, Exp. 7/16/2018
Distribution pattern: NY only
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up