Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
Reported: May 24, 2023 Initiated: May 15, 2023 #D-0601-2023
Product Description
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Astral SteriTech Private Ltd.
- Units Affected
- 119,340 vials
- Distribution
- Nationwide within the United States
- Location
- Vadodara, N/A
Frequently Asked Questions
What product was recalled? ▼
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02. Recalled by Astral SteriTech Private Ltd.. Units affected: 119,340 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 24, 2023. Severity: Moderate. Recall number: D-0601-2023.
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