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 Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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, 29-Sep-15, e) 25-Sep-15, 1-Oct-15, f) 28-Sep-15, 29-Sep-15, 1-Oct-15, g) 25-Sep-15, h) 25-Sep-15, 27-Sep-15, 29-Sep-15, i) 29-Sep-15, j) 25-Sep-15, 26-Sep-15, k) 29-Sep-15, l) 25-Sep-15, 27-Sep-15, 30-Sep-15, m) 1-Oct-15
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Sentara Enterprises
Reason for Recall:
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

Product Codes/Lot Numbers:

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, 29-Sep-15, e) 25-Sep-15, 1-Oct-15, f) 28-Sep-15, 29-Sep-15, 1-Oct-15, g) 25-Sep-15, h) 25-Sep-15, 27-Sep-15, 29-Sep-15, i) 29-Sep-15, j) 25-Sep-15, 26-Sep-15, k) 29-Sep-15, l) 25-Sep-15, 27-Sep-15, 30-Sep-15, m) 1-Oct-15

Distribution:

Distributed in: VA, NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0623-2016

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