CLASS II Drug recall · Reported 22 Feb 2023 · FDA Enforcement Report
Piperacillin / Tazobactam (a) 4.5GM IN NS recalled
Sentara Infusion Services is recalling Piperacillin / Tazobactam (a) 4.5GM IN NS, (b)18GM IN NS 267M, (c) 27GM IN NS, (d) 3.375, distributed nationwide in the US. The recall was initiated on 27 Dec 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-0315-2023
- FDA event ID
- 91466
- Recalling firm
- Sentara Infusion Services, Chesapeake, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2022
- FDA classified
- 15 Feb 2023
- Reported
- 22 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 27 Dec 2022 | Recall initiated by company | |
| 15 Feb 2023 | Classified by FDA | +50 days |
| 22 Feb 2023 | Published in enforcement report | +7 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 sterility assurance
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
PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Where it was distributed
Dispensed to Patients Nationwide.
Questions about this recall
Why was it recalled?
Lack of sterility assurance
Which lots are affected?
Beyond Use Date: December 25-31, 2022
Where was it sold?
Dispensed to Patients Nationwide.
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
52 other products · FDA event 91466This product is part of a recall event; the main page for the event is Hydromorphone (a) 1MG/ML IN NS recalled by Sentara Infusion Services.
More recalls from Sentara Infusion Services
All 53| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Intralipid 18gm, Tpn recalled by Sentara Infusion Services | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Amikacin 450MG IN NS, Antibiotic, used in a Homepump recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin 12GM IN NS 600M, used with a Curlin pump recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP, (b)90GM/AA recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Daptomycin (a) 400MG IN NS, (b) 550MG IN NS, antibiotic recalled | Sentara Infusion Services | Sterility | Nationwide |