Ampicillin for injection recalled nationwide due to sterility concerns
Ampicillin for Injection (2g per vial) is being recalled nationwide because the manufacturer cannot assure the product meets sterility standards. All 45,160 affected vials in circulation are included.
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 antibiotic medication. While no illnesses or injuries have been reported, the lack of sterility assurance for an injectable product represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Piramal Critical Care, in cooperation with the FDA, is recalling Ampicillin for Injection, USP 2g per vial (NDC 66794-223-41), manufactured by Astral SteriTech Private Ltd. The recall affects 45,160 vials that have been distributed nationwide within the United States. All lots currently within expiration are included in the recall.
The recall was initiated because the manufacturer cannot provide adequate assurance that the product meets sterility standards. Ampicillin is an antibiotic used to treat bacterial infections.
Healthcare providers and patients should contact their healthcare provider if they have questions or concerns about this medication. Patients should not discontinue or discard medication without consulting a healthcare professional first.
The FDA is continuing to monitor this recall situation. For additional information, contact Piramal Critical Care or the FDA.
The recalled product
- Product
- Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
- 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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