← FDA ENFORCEMENT
D-0141-2024Class II

Wells Pharma of Houston LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Wells Pharma of Houston LLC
Product type
Drug
Status
Completed
Report date
2023-12-13
Distribution
Philadelphia, Pennsylvania.
Firm state
TX
Product quantity
825 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of assurance of sterility.

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →