Ampicillin for Injection Recalled Due to Sterility Assurance Concerns
Ampicillin for Injection (500 mg/vial) is being recalled nationwide due to inability to assure sterility. The recall covers approximately 59,530 vials.
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 with no reported illnesses or injuries. It involves a risk-of-harm product (injectable medication) where sterility assurance is lacking, but no patient harm has been documented.
Plain-English summary
Ampicillin for Injection, USP 500 mg per vial (NDC 70594-085-02) is being recalled. The product is manufactured by Astral SteriTech Private Ltd. for Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL. Approximately 59,530 vials of all lots remaining within expiration date have been distributed nationwide within the United States.
The recall is being issued due to lack of assurance of sterility. The manufacturer cannot confirm that this injectable antibiotic product meets required sterility standards.
The recalled product
- Product
- Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable antibiotic
- Hazard
- Affected units
- 59,530
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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