Home / Recalls / Sentara Enterprises / D-0628-2016

D-0628-2016 Class II Terminated

Recalled by Sentara Enterprises — Chesapeake, VA

Recall Details

Product Type
Drugs
Report Date
February 3, 2016
Initiation Date
September 18, 2015
Termination Date
June 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 3 Bags, b) 60 Bags

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Distribution Pattern

U.S. Including: VA, NC

Code Information

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

Other recalls by Sentara Enterprises

  • D-0630-2016 Class II — ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, (September 18, 2015)
  • D-0641-2016 Class II — GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, an (September 18, 2015)
  • D-0632-2016 Class II — PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Ho (September 18, 2015)
  • D-0633-2016 Class II — FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA H (September 18, 2015)
  • D-0644-2016 Class II — MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTAR (September 18, 2015)
  • D-0626-2016 Class II — GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML (September 18, 2015)
  • D-0623-2016 Class II — VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Home (September 18, 2015)
  • D-0631-2016 Class II — MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, R (September 18, 2015)
  • D-0625-2016 Class II — HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepu (September 18, 2015)
  • D-0616-2016 Class II — Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML H (September 18, 2015)