Ampicillin and Sulbactam Injection Recalled Due to Sterility Concerns
Astral SteriTech is recalling Ampicillin and Sulbactam for Injection due to inability to assure product sterility. Approximately 357,550 vials distributed nationwide; no illnesses have been reported.
What this means for you
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 an injectable medication with sterility assurance concerns but no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a Score 3 (High).
Plain-English summary
Astral SteriTech Private Ltd. is recalling all lots of Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial (NDC 66794-206-41), manufactured for Piramal Critical Care, due to lack of assurance of sterility. The product is a prescription injectable antibiotic combination used to treat bacterial infections.
The recall encompasses approximately 357,550 vials distributed nationwide within the United States. All affected lots remain within their expiration dates. No illnesses or injuries related to this product have been reported to date.
Healthcare providers and patients with this product should discontinue use of remaining stock. Contact your pharmacy or healthcare provider with questions about your treatment or for information on alternative medications.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Hazard
- sterility-assurance
- contamination-risk
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.
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