FDA recall D-0531-2023

Pine Pharmaceuticals, LLC · Class III · drug

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

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2023-03-27
Report date
2023-04-19
Termination date
2023-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tonawanda, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0531-2023