The Recall Desk
SevereFDA (Drugs)·D-0621-2016·Announced 2016-02-03

Sentara Recalls Ceftriaxone Infusions Due to Sterility Concerns

Sentara Enterprises is recalling specific lots of Ceftriaxone in NS Homepumps because product sterility cannot be guaranteed. The recall affects 82 bags 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 and involves a lack of assurance of sterility, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Sentara Enterprises is recalling specific lots of Ceftriaxone in NS, packaged as Homepumps, due to a lack of assurance of sterility. The affected products are prescription-only and were compounded between September 11, 2015, and September 17, 2015. The recall includes 8 bags of 1GM in 50ML, 70 bags of 2GM in 100ML, and 4 bags of 8GM in 200ML.

The recall was initiated because the sterility of the product cannot be guaranteed. The affected lots were distributed in the United States, specifically in Virginia and North Carolina. The expiration dates for the recalled products range from September 21, 2015, to September 27, 2015.

Consumers and healthcare providers should stop using the affected products immediately. Patients who have received these infusions should contact their healthcare provider for further instructions. The recall is classified as FDA Class II.

The recalled product

Product
CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Manufacturer
Sentara Enterprises
Category
Drug — Antibiotic Infusion
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) 26-Sep-15
  • 27-Sep-15
  • b) 21-Sep-15
  • 24-Sep-15
  • 25-Sep-15
  • 26-Sep-15
  • c) 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 →

Related recalls

Same manufacturer · Sentara Enterprises

See all →

Same hazard · sterility

See all →