The Recall Desk
SevereFDA (Drugs)·D-0628-2016·Announced 2016-02-03

Sentara Recalls Invanz Injection Homepumps Due to Sterility Concerns

Sentara Enterprises is recalling specific lots of Invanz (ertapenem) injection 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. Per the rubric, FDA Class II recalls involving potential adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), especially given the lack of reported illnesses which prevents a higher classification but the inherent risk of non-sterile injectables.

Plain-English summary

Sentara Enterprises is recalling Invanz (ertapenem) Injection Recon Soln in NS, packaged as 500mg in 50ml and 1gm in 100ml homepumps. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed. The affected lots were compounded between September 11, 2015, and September 17, 2015.

The recall involves 3 bags of the 500mg formulation and 60 bags of the 1gm formulation. These products were distributed in the United States, specifically in Virginia and North Carolina. The expiration dates for the affected lots range from September 19, 2015, to September 25, 2015.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Manufacturer
Sentara Enterprises
Category
Drug — Injectable Antibiotic
Hazard

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 (7)

  • All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 22-Sep-15
  • b) 19-Sep-15
  • 20-Sep-15
  • 22-Sep-15
  • 23-Sep-15
  • 24-Sep-15
  • 25-Sep-15

Distribution

Distributed in 2 states:

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 →

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Same hazard · sterility

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