CLASS II Drug recall · Reported 24 May 2023 · FDA Enforcement Report
Ceftriaxone for Injection, USP 250 mg per vial recalled
Astral SteriTech Private is recalling Ceftriaxone for Injection, USP 250 mg per vial, distributed nationwide in the US. The recall was initiated on 15 May 2023 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes All lots within expiry.
Quantity recalled 66,250 vials
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Recall number D-0611-2023
FDA event ID 92341
Classification Class II
Status Terminated
Recall initiated 15 May 2023
FDA classified 18 May 2023
Reported 24 May 2023
Type Voluntary: Firm initiated
Customers notified by Letter
Timeline
15 May 2023 Recall initiated by company 18 May 2023 Classified by FDA +3 days 24 May 2023 Published in enforcement report +6 days
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42
Where it was distributed
Nationwide within the United States
Nationwide
Questions about this recall
Why was it recalled? Lack of Assurance of Sterility
Which lots are affected? All lots within expiry.
Where was it sold? Nationwide within the United States
What should I do if I have it? Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean? Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 51 other products · FDA event 92341 This product is part of a recall event; the main page for the event is Piperacillin and Tazobactam for Injection, USP per vial recalled .
Reported Class Recall Company Reason Where 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP per Pharmacy recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP vials recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP 500 mg per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Cefepime for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per Pharmacy recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Cefepime for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Cefepime for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Cefepime for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per Pharmacy recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Cefepime for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP 500 mg per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP per Pharmacy recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, UPS per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP 250 mg per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per Pharmacy recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP, 250 mg per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP 500 mg per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP per Pharmacy recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per Pharmacy recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP 250 mg per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Cefepime for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin for Injection, USP 500 mg per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ceftriaxone for Injection, USP per Pharmacy recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Ampicillin and Sulbactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Cefepime for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide 24 May 2023 CLASS II Piperacillin and Tazobactam for Injection, USP per vial recalled Astral SteriTech Private Sterility Nationwide
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