Ampicillin Injection Vials Recalled for Sterility Assurance Failure
Astral SteriTech is recalling approximately 89,690 vials of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide.
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 injectable drug product lacking sterility assurance. No illnesses or injuries have been reported. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Astral SteriTech Private Ltd. is recalling approximately 89,690 vials of Ampicillin for Injection, USP 1g per vial (NDC 66794-222-41), manufactured for Piramal Critical Care, due to lack of assurance of sterility.
The affected vials were distributed nationwide within the United States. Sterility is critical for injectable medications, and failure to ensure sterile conditions creates a risk of microbial contamination.
Patients and healthcare providers who have received or are currently using affected vials should consult with their healthcare provider or pharmacist regarding their treatment.
The recalled product
- Product
- Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 89,690
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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