Home / Recalls / Lincare, Inc. / D-1156-2015

D-1156-2015 Class II Terminated

Recalled by Lincare, Inc. — Little Rock, AR

FDA drug recall D-1156-2015 was initiated by Lincare, Inc. on May 28, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Sterility of product is not assured. The recall status is terminated (terminated February 16, 2017). Affected quantity: 3 Bags.

Recall Details

Product Type
Drugs
Report Date
July 8, 2015
Initiation Date
May 28, 2015
Termination Date
February 16, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 Bags

Product Description

TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Infuvitm Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Reason for Recall

Lack of Assurance of Sterility: Sterility of product is not assured.

Distribution Pattern

United States including: Arkansas

Code Information

All product compounded between May 14, 2015 and May 27, 2015

Other recalls by Lincare, Inc.

  • D-1157-2015 Class II — TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10 (May 28, 2015)
  • D-1164-2015 Class II — TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralip (May 28, 2015)
  • D-1160-2015 Class II — TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralip (May 28, 2015)
  • D-1158-2015 Class II — TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 1 (May 28, 2015)
  • D-1205-2015 Class II — Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes (May 28, 2015)
  • D-1191-2015 Class II — Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. Com (May 28, 2015)
  • D-1165-2015 Class II — TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clini (May 28, 2015)
  • D-1193-2015 Class II — Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only. (May 28, 2015)
  • D-1163-2015 Class II — TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intrali (May 28, 2015)
  • D-1168-2015 Class II — Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: Unit (May 28, 2015)

FDA data resources