Ampicillin for Injection Recalled Due to Lack of Sterility Assurance
Astral SteriTech is recalling 17,350 vials of Ampicillin for Injection nationwide because the manufacturer cannot assure the product's sterility. Healthcare providers and patients should consult their healthcare provider about exposure.
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 a sterile injectable medication where the manufacturer cannot assure sterility. This is a risk-of-harm product, as non-sterile injectables can cause serious infection. No illnesses or injuries have been reported. This fits the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Astral SteriTech Private Ltd. is recalling 17,350 vials of Ampicillin for Injection, USP 500 mg per vial, manufactured for Piramal Critical Care (Bethlehem, PA). The recall encompasses all lots currently within their expiration date and applies to nationwide distribution within the United States.
The FDA has classified this as a Class II recall due to lack of assurance of sterility. Ampicillin for Injection is an injectable antibiotic that is required to be sterile for safe use. The manufacturer cannot provide adequate assurance that the manufacturing process maintained the required sterility standards throughout production, packaging, and storage.
Healthcare facilities and providers should identify and remove any remaining product from dispensing locations. Patients and healthcare providers who may have received this medication should contact a healthcare provider to discuss potential exposure and any health concerns. Facilities with unused product should contact their supplier for instructions on return or disposal.
The recalled product
- Product
- Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Hazard
- lack-of-sterility
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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