Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Concerns
Xellia Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. Approximately 23,187 bottles were distributed nationwide; patients should consult their healthcare provider.
What this means for you
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 lack of sterility assurance in an injectable antibiotic. While no illnesses or injuries are reported in the source, the potential for serious infection from non-sterile injectable medication constitutes a high-risk situation.
Plain-English summary
Xellia Pharmaceuticals USA, LLC, has recalled Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package (NDC 70594-083-01) due to lack of assurance of sterility. The manufacturer, Astral SteriTech Private Ltd., is unable to guarantee that the product meets sterility standards required for safe injection.
Approximately 23,187 bottles of this injectable antibiotic were distributed nationwide in the United States. All affected lots are currently within their expiration dates. Because this is an injectable medication, the maintenance of sterility standards is critical to patient safety.
Healthcare facilities and pharmacies that received this product should immediately cease dispensing and quarantine all affected inventory. Patients who have received this medication should consult their healthcare provider with any concerns. Additional information, including specific lot numbers, is available from the FDA or the recalling manufacturer.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 23,187
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.
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