Ceftriaxone for Injection Recalled Due to Sterility Assurance Issue
Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 pharmaceutical due to manufacturing quality control failure. While the hazard (compromised sterility) poses a genuine risk to patient safety, no illnesses, injuries, or deaths have been reported. Per the rubric, risk-of-harm products without reported injury score at most High (3).
Plain-English summary
Astral SteriTech Private Ltd. is recalling Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package (NDC 66794-215-15), manufactured for Piramal Critical Care, Bethlehem, PA. A total of 9,040 bottles have been distributed nationwide throughout the United States.
The recall was initiated due to lack of assurance of sterility. Ceftriaxone is an injectable antibiotic used in hospitals and clinical settings for treating serious infections. Compromised sterility could potentially allow bacterial or microbial contamination, posing a risk to patients who receive this medication.
All affected lots remain within their labeled expiration dates. Healthcare providers, hospitals, pharmacies, and patients who possess this product should contact their healthcare provider or pharmacy for instructions on handling and disposal. No illnesses or adverse events have been reported to date.
The recalled product
- Product
- Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Affected units
- 9,040
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.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 52 products in this recall →Related recalls
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