Recalls / Class III
Class IIID-0607-2018
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
- Affected lot / code info
- Lot#: 18098@1, Exp. 7/16/2018
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.
Recalling firm
- Firm
- Pine Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Colvin Woods Pkwy, Ste 300, Tonawanda, New York 14150-6974
Distribution
- Quantity
- 136 units
- Distribution pattern
- NY only
Timeline
- Recall initiated
- 2018-03-05
- FDA classified
- 2018-03-26
- Posted by FDA
- 2018-03-28
- Terminated
- 2018-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0607-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.