March 2023 FDA Recall Drug by Pine Pharmaceuticals, Llc
D-0531-2023 - Labeling

This Class III drug recall was voluntarily initiated by Pine Pharmaceuticals, Llc on March 27, 2023 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0531-2023

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Initiated
03-27-2023
Reported
04-19-2023
Quantity
932 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91972
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-01-2023
Product Description About Product Description
Full technical description of the product.
Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary packaging consists of a coated cardboard box, with order-specific label indicating lot number housed within order/container. NDC # 69194-0458-1

Batch or Lot Expiration Information

Lot# 66377, Exp. Date: 06/28/2023. Syringe may be labeled incorrectly as
Lot# 66316