November 2023 FDA Recall Drug by Wells Pharma Of Houston Llc
D-0141-2024 - Lack of assurance of sterility.

This Class II drug recall was voluntarily initiated by Wells Pharma Of Houston Llc on November 22, 2023 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility.. The product was distributed in Philadelphia, Pennsylvania. and the recall is currently completed.

Recall Number: D-0141-2024

Reason for Recall
Lack of assurance of sterility.
Initiated
11-22-2023
Reported
12-13-2023
Quantity
825 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93496
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wells Pharma of Houston LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Philadelphia, Pennsylvania.
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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