Sentara Recalls ZOSYN Homepumps Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of ZOSYN (piperacillin/tazobactam) homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), especially when no specific hospitalization reports are provided to elevate it to Critical, but the risk is significant enough to warrant a high severity rating.
Plain-English summary
Sentara Enterprises is recalling ZOSYN (piperacillin/tazobactam) in NS, packaged in various Homepump sizes, due to a lack of assurance of sterility. The recall covers specific lots compounded between September 11, 2015, and September 17, 2015, with expiration dates ranging from September 25, 2015, to October 1, 2015.
The affected products include 56 bags of 3.375GM in 50ML, 28 bags of 4.5GM in 100ML, 4 bags of 18GM in 267ML, 10 bags of 27GM in 400ML, and 2 bags of 36GM in 533ML. These prescription-only products were distributed in the United States, specifically in Virginia and North Carolina.
Patients and healthcare providers should stop using the affected ZOSYN homepumps and contact their healthcare provider or Sentara Enterprises for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 29-Sep-15
- d) 26-Sep-15
- 29-Sep-15 e) 1-Oct-15
Distribution
Part of a larger recall action
This product is one of 34 recalled by Sentara Enterprises under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 34 products in this recall →Related recalls
Same manufacturer · Sentara Enterprises
See all →- SevereSentara Recalls Nafcillin Bags Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-02-03
- HighSentara Recalls Sodium Chloride Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Tobramycin Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Gentamicin Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29