CLASS II Drug recall · Reported 24 May 2023 · FDA Enforcement Report
Ampicillin for Injection, USP 500 mg per vial recalled
Astral SteriTech Private is recalling Ampicillin for Injection, USP 500 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
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-0581-2023
- FDA event ID
- 92341
- Recalling firm
- Astral SteriTech Private, Vadodara, N/A
- 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
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
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
Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Ampicillin for Injection, USP 500 mg per vial recalled?
Yes. Astral SteriTech Private recalled Ampicillin for Injection, USP 500 mg per vial on 15 May 2023. The recall is Class II and its status is Terminated. Recall number D-0581-2023.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Astral SteriTech Private
All 52| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Cefepime for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
Other Ampicillin recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ampicillin for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP, 250 mg per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP 250 mg per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |