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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 2,862
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.
Part of a larger recall action
This product is one of 16 recalled by Pine Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
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