Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Ampicillin for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02
Affected NDC
70594-0084-02
Compare with the code on your package — it is the most precise check available.
Drug: Ampicillin
- Recalling firm
- Astral SteriTech Private Ltd.
- NDC code
- 70594-084-02
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0585-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ampicillin recalls
See all
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Other recalls by Astral SteriTech Private Ltd.
All 2023 recalls
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
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