CLASS II Drug recall · Reported 17 Jun 2020 · FDA Enforcement Report
Unasyn (ampicillin sodium/sulbacatam) for injection* per vial recalled
Pfizer is recalling Unasyn (ampicillin sodium/sulbacatam) for injection* per vial, distributed nationwide in the US. The recall was initiated on 29 May 2020 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-1306-2020
- FDA event ID
- 85754
- Recalling firm
- Pfizer, New York, NY
- Brand
- Unasyn
- Manufacturer
- Roerig
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2020
- FDA classified
- 12 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 29 May 2020 | Recall initiated by company | |
| 12 Jun 2020 | Classified by FDA | +14 days |
| 17 Jun 2020 | Published in enforcement report | +5 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: particulate matter identified after reconstitution.
Product as listed by the FDA
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83
Where it was distributed
Distributed Nationwide in the US
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particulate matter identified after reconstitution.
Which lots are affected?
Lot # 3301612, EXP 02/2022
Where was it sold?
Distributed Nationwide in the US
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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