CLASS II Drug recall · Reported 5 Oct 2022 · FDA Enforcement Report
Ampicillin for Injection recalled by Viatris
Viatris is recalling Ampicillin for Injection, USP, distributed nationwide in the US. The recall was initiated on 21 Sep 2022 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-1542-2022
- FDA event ID
- 90886
- Recalling firm
- Viatris, Canonsburg, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2022
- FDA classified
- 23 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Sep 2022 | Recall initiated by company | |
| 23 Sep 2022 | Classified by FDA | +2 days |
| 5 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Product as listed by the FDA
Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Which lots are affected?
Lot 7105130, exp 9/2023
Where was it sold?
Nationwide in the USA
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.
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|---|---|---|---|---|---|
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Other Ampicillin recalls
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP 500 mg per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |