Cefepime for Injection recalled nationwide for lack of sterility assurance
Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.
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 pharmaceutical injection product where the manufacturer cannot assure adequate sterility. Sterile injectables are high-risk products where sterility defects can cause serious infections. No illnesses have been reported in the source text.
Plain-English summary
Astral SteriTech Private Ltd. is recalling Cefepime for Injection, USP, 1 gram per vial (NDC 66794-209-41) distributed nationwide. All lots currently within their expiration dates are included in the recall. The product is being recalled because the manufacturer cannot provide adequate assurance that the product meets sterility standards required for safe injection.
Cefepime for Injection is a prescription-only medication available in the United States. The recall affects approximately 41,320 vials.
Healthcare providers and pharmacies should stop distribution of this product immediately. Patients currently using this medication should contact their healthcare provider to discuss alternative treatment options. The recalled product should not be used.
The recalled product
- Product
- Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug
- Hazard
- lack-of-sterility-assurance
- infection-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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