Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Defect
The FDA has recalled Ampicillin and Sulbactam for Injection due to lack of assured sterility. Approximately 119,340 vials distributed nationwide within the United States are affected.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for an injectable medication with a potential sterility defect. With no illnesses or injuries reported in the source material, the hazard is theoretical, placing it at Score 3 (High) per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Astral SteriTech Private Ltd., manufacturing for Xellia Pharmaceuticals USA, LLC, has recalled Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial due to lack of assured sterility. Approximately 119,340 vials were distributed nationwide within the United States, with all lots currently within their expiration dates included in the recall.
The product is identified by NDC number 70594-081-02. The FDA issued this Class II recall to address the potential sterility defect. Additional information is available through the FDA's drug safety and recall database.
The recalled product
- Product
- 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
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 119,340
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 52 products in this recall →Related recalls
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