The Recall Desk
HighFDA (Drugs)·D-0050-2024·Announced 2023-10-25

Compounded Bevacizumab Injectable Syringes Recalled for Sterility Assurance

Pine Pharmaceuticals is recalling approximately 2,862 syringes of compounded Bevacizumab 1.25 MG/0.05 ML Solution for Injection due to lack of assurance of sterility. The product was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall of a compounded injectable pharmaceutical due to lack of assurance of sterility. While no illnesses or injuries are reported, sterility assurance failure in injectable medications represents a potential risk of contamination and serious harm.

Plain-English summary

Pine Pharmaceuticals, LLC is recalling compounded Bevacizumab 1.25 MG/0.05 ML Solution for Injection in 1 mL syringes due to lack of assurance of sterility. Approximately 2,862 syringes are affected, distributed nationwide within the United States.

Multiple lot numbers are included in the recall, with expiration dates from October 2023 through January 2024. Lack of assurance of sterility in injectable medications poses a potential risk of microbial contamination.

The recalled product

Product
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Manufacturer
Pine Pharmaceuticals, LLC
Hazard
  • sterility-failure

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 (20)

  • Lot #: 68622
  • 68620 Exp. Date 10/3/2023
  • 68632 Exp. Date 10/4/2023
  • 68699
  • 68704
  • 68706 Exp. Date 10/6/2023
  • 68726
  • 68740 Exp. Date 10/7/2023
  • 68784 Exp. Date 10/11/2023
  • 68843
  • 68861
  • Exp. Date 10/13/2023
  • 68789
  • 68822 Exp. Date 10/12/2023
  • 68914 Exp. Date 10/17/2023
  • 68952
  • 68954
  • 68980 Exp. Date 10/18/2023
  • 69105 Exp. Date 10/25/2023
  • 69731 Exp. Date 11/7/2023

Distribution

Distributed nationwide across the United States.