Ampicillin and Sulbactam Injection Recalled Over Sterility Assurance Failure
The FDA is recalling 11,555 bottles of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The nationwide recall affects all lots within expiry.
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 Class II FDA drug recall involves a sterility assurance failure affecting an injectable medication. No illnesses or injuries are reported in the source. However, lack of sterility assurance for an injectable drug represents a significant risk-of-harm product where injury has not yet been reported, meeting the criteria for Score 3 (High).
Plain-English summary
The FDA is recalling Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, manufactured by Astral SteriTech Private Ltd. for Piramal Critical Care, Bethlehem, PA (NDC 66794-208-15). The recall affects 11,555 bottles, with all lots currently within expiration dates.
The recall was issued due to lack of assurance of sterility. Sterile formulation is a critical requirement for injectable medications.
The product was distributed nationwide throughout the United States. Patients and healthcare providers who have received this medication should contact their pharmacy or healthcare facility for guidance regarding affected stock.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Affected units
- 11,555
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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