ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syr...

FDA Recall #D-0141-2024 — Class II — November 22, 2023

Recall #D-0141-2024 Date: November 22, 2023 Classification: Class II Status: Completed

Product Description

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

Reason for Recall

Lack of assurance of sterility.

Recalling Firm

Wells Pharma of Houston LLC — Houston, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

825 syringes

Distribution

Philadelphia, Pennsylvania.

Code Information

Lot # 11092313110#01, Exp 01/12/24

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated