Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Deficiency
Ampicillin and Sulbactam for Injection is being recalled nationwide because the manufacturer cannot assure sterility of 591,160 vials distributed throughout the United States.
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 an FDA Class II recall for a sterility assurance issue with no reported illnesses. The injectable nature of this antibiotic product represents a potential risk of harm, but absent hospitalization reports, the severity is High rather than Severe.
Plain-English summary
Ampicillin and Sulbactam for Injection, USP 3 grams per vial (NDC 70594-082-02), is being recalled due to a lack of assurance of sterility. The product was manufactured by Astral SteriTech Private Ltd. for Xellia Pharmaceuticals USA, LLC, and distributed nationwide throughout the United States.
Approximately 591,160 vials have been distributed. The recall affects all lots of this product remaining within their expiration date. The FDA has classified this as a Class II recall.
Patients and healthcare providers with questions should contact the manufacturer or their healthcare provider regarding this recall.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable
- Affected units
- 591,160
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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