Home / Recalls / Sentara Enterprises / D-0614-2016

D-0614-2016 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) 7, b) 7, c) 6, d) 7, e) 4, f) 13, g) 2, h) 4, i) 7, j) 5, k) 10, l) 11, m) 11, n) 11, o) 7, p) 7, q) 7 Bags

Product Description

Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML 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) 26-Sep-15, b) 16-Sep-15 c) 25-Sep-15, d) 25-Sep-15 e) 20-Sep-15, 26-Sep-15, f) 20-Sep-15, 24-Sep-15, g) 20-Sep-15, 26-Sep-15, h) 20-Sep-15, i) 15-Sep-15, j) 26-Sep-15, k) 25-Sep-15, 26-Sep-15, l) 20-Sep-15, 23-Sep-15, m) 20-Sept-15, 24-Sep-15, 26-Sep-15, n) 23-Sep-15, o) 20-Sep-15, p) 26-Sep-15, q) 20-Sep-15

Other recalls by Sentara Enterprises

  • D-0628-2016 Class II — Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Home (September 18, 2015)
  • 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-0616-2016 Class II — Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML H (September 18, 2015)