Ampicillin Injection Recalled for Lack of Sterility Assurance
Astral SteriTech has recalled approximately 7,214 bottles of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide within the United States.
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 is an FDA Class II recall of an injectable pharmaceutical due to lack of assurance of sterility, representing a risk-of-harm product where injury has not yet been reported. No illnesses, injuries, or deaths have been reported in the source material.
Plain-English summary
Astral SteriTech Private Ltd. has recalled Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, manufactured for Xellia Pharmaceuticals USA, LLC. Approximately 7,214 bottles with National Drug Code (NDC) 70594-088-01 are included in the recall. All lots within expiry have been recalled.
The recall was initiated due to lack of assurance of sterility in the manufacturing process. This manufacturing defect could potentially compromise the safety of the injectable medication.
The affected product was distributed nationwide within the United States. Healthcare providers, pharmacies, and patients in possession of this medication should cease use and contact Astral SteriTech or their healthcare provider for guidance on appropriate actions regarding returns or destruction of the product.
The recalled product
- Product
- Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Hazard
- lack-of-sterility
- manufacturing-defect
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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