D-0531-2023 Class III Terminated
FDA drug recall D-0531-2023 was initiated by Pine Pharmaceuticals, LLC on Mar 27, 2023 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. The recall status is terminated (terminated Jun 1, 2023). Affected quantity: 932 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 19, 2023
- Initiation Date
- Mar 27, 2023
- Termination Date
- Jun 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 932 syringes
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot # 66377, Exp. Date: 06/28/2023. Syringe may be labeled incorrectly as lot# 66316
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0531-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026