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D-0644-2016 Class II Terminated

Recalled by Sentara Enterprises — Chesapeake, VA

FDA drug recall D-0644-2016 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: 10 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
10 Bags

Product Description

MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML 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: 24-Sep-15, 27-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-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-0638-2016 Class II — AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOM (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