Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in indiv
Summary
The FDA issued a Class III for Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip by Pine Pharmaceuticals, LLC. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect..
Details
Source
Drug Recall
External ID
D-0531-2023
Action Date
2023-04-19
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 66377, Exp. Date: 06/28/2023. Syringe may be labeled incorrectly as lot# 66316
Quantity Affected: 932 syringes
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-27
Company
Tonawanda, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 63 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pine Pharmaceuticals, LLC has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pine Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pine Pharmaceuticals, LLC have FDA actions?
Pine Pharmaceuticals, LLC has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0531-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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