Home / Recalls / Sentara Enterprises / D-0638-2016

D-0638-2016 Class II Terminated

Recalled by Sentara Enterprises — Chesapeake, VA

FDA drug recall D-0638-2016 was initiated by Sentara Enterprises on September 18, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Product sterility cannot be guaranteed. The recall status is terminated (terminated June 29, 2016). Affected quantity: 12 Bags.

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
12 Bags

Product Description

AZACTAM (aztreonam) 2GM in NS, Packaged 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. Expiry: 30-Sep-15

Other recalls by Sentara Enterprises

  • 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-0644-2016 Class II — MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTAR (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-0623-2016 Class II — VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Home (September 18, 2015)
  • D-0637-2016 Class II — Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx O (September 18, 2015)
  • D-0615-2016 Class II — CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1 (September 18, 2015)
  • D-0613-2016 Class II — SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 2 (September 18, 2015)
  • D-0614-2016 Class II — Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Ho (September 18, 2015)
  • D-0621-2016 Class II — CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepum (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)

FDA data resources