The Recall Desk
ModerateFDA (Drugs)·D-0531-2023·Announced 2023-04-19

Bevacizumab Injection Recall Due to Incorrect Lot Number Labeling

Pine Pharmaceuticals is recalling 932 syringes of Bevacizumab 2.5 mg/0.1 mL due to incorrect lot number labeling on the primary packaging. The affected lot (#66377, expiration 06/28/2023) was distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall for incorrect lot number labeling on primary packaging. No illnesses or injuries reported. The issue is a labeling error affecting product identification and traceability but not the product safety itself. Minor labeling errors without reported harm are classified as Moderate severity per the rubric.

Plain-English summary

Pine Pharmaceuticals, LLC is recalling Bevacizumab 2.5 mg/0.1 mL, Solution for Injection. The recalled product is supplied in 1 mL syringes with silicone-free slip-tip design (NDC # 69194-0458-1). The recall affects 932 syringes from Lot # 66377 with an expiration date of 06/28/2023. Each syringe is provided in an individually labeled poly envelope (primary packaging) housed within a coated cardboard box with an order-specific label (secondary packaging).

The lot number code on the primary packaging is labeled incorrectly. Syringes from this lot may be labeled with lot # 66316 instead of the correct lot # 66377. This labeling error affects product identification and traceability.

The affected product was distributed nationwide in the United States. Healthcare providers and facilities that received this product should identify any units from the affected lot and should not administer affected units. This is a Class III FDA recall (recall number D-0531-2023).

The recalled product

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, Offic
Manufacturer
Pine Pharmaceuticals, LLC
Category
Drug — Injectable
Hazard
  • mislabeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category