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
D-0531-2023
Product summary
- Event
- Event 91972
- Status
- Terminated
- Classification
- Class III
- Quantity
- 932 syringes
- Official record key
drug-enforcement:D-0531-2023
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Code information: Lot # 66377, Exp. Date: 06/28/2023. Syringe may be labeled incorrectly as lot# 66316
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing