Ampicillin for Injection Recalled for Lack of Sterility Assurance
Ampicillin for Injection is being recalled by Xellia Pharmaceuticals because the manufacturer cannot assure the vials are sterile. The nationwide recall involves 220,340 vials.
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 lack of sterility assurance in an injectable antibiotic. Per the severity rubric, a risk-of-harm product without reported injury is classified as High. Injectable drugs with potential contamination present serious risk to patient safety.
Plain-English summary
Xellia Pharmaceuticals USA, LLC is recalling Ampicillin for Injection, USP 2 g per vial (NDC 70594-087-02), manufactured by Astral SteriTech Private Ltd. The recall was initiated because the manufacturer cannot assure that all vials meet sterility standards.
Ampicillin for Injection is an antibiotic administered by injection. The recall affects 220,340 vials distributed nationwide throughout the United States, including all lots currently within their expiration dates. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 220,340
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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