CLASS II Drug recall · Reported 13 Dec 2023 · FDA Enforcement Report
ceFAZolin sodium in Sterile Water for injection recalled
Wells Pharma of Houston is recalling ceFAZolin sodium in Sterile Water for injection, Injectable Solution per mL), Syringe, distributed in Pennsylvania. The recall was initiated on 22 Nov 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0141-2024
- FDA event ID
- 93496
- Recalling firm
- Wells Pharma of Houston, Houston, TX
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 22 Nov 2023
- FDA classified
- 6 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Nov 2023 | Recall initiated by company | |
| 6 Dec 2023 | Classified by FDA | +14 days |
| 13 Dec 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Philadelphia, Pennsylvania.
Questions about this recall
Why was it recalled?
Lack of assurance of sterility.
Which lots are affected?
Lot # 11092313110#01, Exp 01/12/24
Where was it sold?
Philadelphia, Pennsylvania.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Wells Pharma of Houston
All 8Other Cefazolin recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cefazolin in Dextrose, Injection recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
| Drug | CLASS II | Cefazolin 5mg/mL/Heparin/ml Syr, antibiotic recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Cefazolin for injection USP, and Dextrose Injection recalledCefazolin Sodium | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cefazolin for injection USP, and Dextrose Injection recalledCefazolin Sodium | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |