Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Failure
Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.
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 FDA Class II recall involves a manufacturing control failure in an injectable medication. As no illnesses or injuries have been reported, it meets the High severity threshold as a risk-of-harm product without reported injury.
Plain-English summary
Ampicillin and Sulbactam for Injection, USP, 3-gram vials manufactured by Astral SteriTech Private Ltd. for Piramal Critical Care has been recalled nationwide. The product is a prescription injectable antibiotic combination.
The manufacturer initiated this Class II recall because it could not assure that all units met sterility standards required for injectable medications. Lack of sterility assurance in injectables poses a risk of contamination with microorganisms.
Approximately 1,001,110 vials with NDC 66794-207-41 are affected. All currently affected units remain within their expiration dates. The product was distributed nationwide throughout the United States.
Patients and healthcare providers who have or use the recalled product should discontinue use immediately. For instructions on returning or disposing of affected units, contact Piramal Critical Care or visit the FDA website.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 1,001,110
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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