The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0623-2016·Announced 2016-02-03

Sentara Recalls Vancomycin HCL Homepumps Due to Sterility Concerns

Sentara Enterprises is recalling Vancomycin HCL home infusion bags because the product's sterility cannot be guaranteed. The recall affects bags distributed in Virginia and North Carolina.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 failure in an injectable drug) are classified as Severe (Score 4), particularly given the rule that FDA Class I/II classifications with significant risk factors do not go below 4.

Plain-English summary

Sentara Enterprises is recalling specific lots of Vancomycin HCL packaged in Homepumps for home infusion. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed. The affected products are prescription-only and were compounded between September 11, 2015, and September 17, 2015.

The recall covers multiple concentrations and volumes of Vancomycin HCL, ranging from 600mg in 120ml to 9000mg in 1800ml. The specific quantities recalled vary by concentration, with total units ranging from 2 to 65 bags per type. The products were distributed in the United States, specifically in Virginia and North Carolina.

Patients and healthcare providers who have received these specific lots of Vancomycin HCL should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML…
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 (17)

  • All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15
  • 30-Sep-15
  • b) 25-Sep-15
  • 29-Sep-15
  • c) 25-Sep-15 d) 25-Sep-15
  • 26-Sep-15
  • e) 25-Sep-15
  • 1-Oct-15
  • f) 28-Sep-15
  • g) 25-Sep-15
  • h) 25-Sep-15
  • 27-Sep-15
  • i) 29-Sep-15
  • j) 25-Sep-15
  • k) 29-Sep-15
  • l) 25-Sep-15
  • m) 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 →

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