Ampicillin for Injection Recalled Due to Sterility Assurance Defect
Astral SteriTech Private Ltd. is recalling Ampicillin for Injection due to manufacturing controls that cannot assure product sterility. The FDA Class II recall affects approximately 80,850 vials distributed nationwide.
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 with a sterility assurance defect affecting an injectable antibiotic. The manufacturing control failure creates a risk of microbial contamination in a high-risk product form (injectable). This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Ampicillin for Injection, USP 1g per vial is being recalled due to lack of assurance of sterility in the manufacturing process. The product is distributed nationwide under NDC 70594-086-02.
The recall affects approximately 80,850 vials. All lots currently within expiry are included. This is an FDA Class II recall initiated by Astral SteriTech Private Ltd., the manufacturer, with product distributed for Xellia Pharmaceuticals USA.
Healthcare providers and patients with questions about current or recent use of this product should consult their healthcare provider for guidance.
The recalled product
- Product
- Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Antibiotic Injectable
- Affected units
- 80,850
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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