The Recall Desk
HighFDA (Drugs)·D-0615-2016·Announced 2016-02-03

Sentara Recalls Cefazolin Due to Lack of Sterility Assurance

Sentara Enterprises is recalling specific lots of Cefazolin because the sterility of the product cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Sentara Enterprises is recalling specific lots of Cefazolin, an antibiotic medication packaged in syringes and homepumps. The recall is due to a lack of assurance of sterility, meaning the company cannot guarantee that the product is sterile.

The affected products include Cefazolin in various concentrations and volumes, including 625mg in 6.2ml syringes, 2gm in 20ml syringes, 1gm in 50ml homepumps, 2gm in 100ml homepumps, and 12gm in 600ml homepumps. All lots were compounded between September 11, 2015, and September 17, 2015. The distribution was limited to the United States, specifically Virginia and North Carolina.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Manufacturer
Sentara Enterprises
Category
Drug — 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 (8)

  • All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15
  • b) 28-Sep-15
  • 29-Sep-15
  • c) 30-Sep-15 d) 28-Sep-15
  • 1-Oct-15 e) 25-Sep-15
  • 28-Sep-15
  • 30-Sep-15
  • 1-Oct-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

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Same hazard · sterility failure

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