D-0607-2018 Class III Terminated
FDA drug recall D-0607-2018 was initiated by Pine Pharmaceuticals, LLC on Mar 5, 2018 and is designated Class III. 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. The recall status is terminated (terminated Apr 23, 2018). Affected quantity: 136 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 28, 2018
- Initiation Date
- Mar 5, 2018
- Termination Date
- Apr 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136 units
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
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.
Distribution Pattern
NY only
Code Information
Lot#: 18098@1, Exp. 7/16/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0607-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026