Injectable Antibiotic Recalled for Lack of Sterility Assurance
Astral SteriTech is recalling 51,280 vials of Cefepime for Injection nationwide because the manufacturer cannot assure that all vials meet sterility requirements. The product is distributed across 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 for lack of sterility assurance in an injectable antibiotic. Although non-sterile injectables pose significant risk for serious infection, the source text reports no confirmed illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Astral SteriTech Private Ltd. is recalling 51,280 vials of Cefepime for Injection, USP 2 grams per vial, manufactured for Piramal Critical Care in Bethlehem, Pennsylvania. The product has been distributed nationwide within the United States.
Cefepime is an injectable antibiotic used to treat bacterial infections. The recall was issued because the manufacturer cannot provide assurance that all vials meet sterility requirements. Sterility is critical for injectable medications, as non-sterile injected products can cause serious patient infection.
All lots currently within their expiration date are included in this recall. Healthcare providers and facilities with the affected product should contact the manufacturer or their supplier for information about replacement supply.
The recalled product
- Product
- Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41
- 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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