March 2018 FDA Recall Drug by Pine Pharmaceuticals, Llc
D-0607-2018 - Labeling

This Class III drug recall was voluntarily initiated by Pine Pharmaceuticals, Llc on March 5, 2018 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in NY only and the recall is currently terminated.

Recall Number: D-0607-2018

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.
Initiated
03-05-2018
Reported
03-28-2018
Quantity
136 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79457
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pine Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-23-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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