Ceftriaxone Injectable Antibiotic Recalled Due to Sterility Assurance Failure
Ceftriaxone for Injection is being recalled due to lack of assurance of sterility. The recall affects 65,950 vials distributed nationwide in the United States.
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: FDA Class II recall for an injectable medication with lack of sterility assurance. No illnesses or injuries have been reported; however, the product poses a risk of contamination in a high-risk category where injury has not yet been reported.
Plain-English summary
Ceftriaxone for Injection, USP 500 mg per vial (NDC 66794-212-42), manufactured by Astral SteriTech Private Ltd. for Piramal Critical Care, is being recalled due to a lack of assurance of sterility.
The recall affects 65,950 vials that have been distributed nationwide within the United States. All lots currently within their expiration dates are included in this recall.
Ceftriaxone is an antibiotic used to treat bacterial infections. Lack of sterility assurance in injectable medications means the vials may not meet required safety and purity standards.
Healthcare providers and patients using this product should contact their healthcare provider for guidance. Recalled vials should be returned to the manufacturer or distributor, or disposed of according to local hazardous waste disposal requirements.
The recalled product
- Product
- Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 65,950
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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