Injectable Antibiotic Ampicillin and Sulbactam Recalled Over Sterility Concerns
Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 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: Lack of sterility assurance in an injectable medication represents a risk-of-harm scenario. The FDA Class II classification indicates potential for serious adverse consequences. Per the severity rubric, this falls within the High category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The FDA is recalling Ampicillin and Sulbactam for Injection, USP 3 gram per vial, manufactured by Astral SteriTech Private Ltd. for Civica Inc. The recall affects 419,680 vials distributed nationwide in the United States.
The product lacks assurance of sterility. Non-sterile injectable medications can introduce harmful microorganisms directly into the bloodstream, potentially causing serious infections.
Patients and healthcare providers currently using this medication should contact their healthcare provider or pharmacist for guidance on obtaining an alternative product.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 419,680
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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