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D-0916-2016 Class II Terminated

Recalled by Baptist Health Medical Towers Pharmacy and Infusion Services — Little Rock, AR

FDA drug recall D-0916-2016 was initiated by Baptist Health Medical Towers Pharmacy and Infusion Services on April 18, 2016 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is terminated (terminated December 23, 2016). Affected quantity: a) 39 bags and b) 8 bags.

Recall Details

Product Type
Drugs
Report Date
June 8, 2016
Initiation Date
April 18, 2016
Termination Date
December 23, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 39 bags and b) 8 bags

Product Description

Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

Reason for Recall

Lack of Sterility Assurance

Distribution Pattern

Arkansas

Code Information

All product remaining within expiry

Other recalls by Baptist Health Medical Towers Pharmacy and Infusion Services

  • D-0943-2016 Class II — Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medica (April 18, 2016)
  • D-0926-2016 Class II — Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE (April 18, 2016)
  • D-0938-2016 Class II — TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medic (April 18, 2016)
  • D-0917-2016 Class II — Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist (April 18, 2016)
  • D-0925-2016 Class II — Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1 (April 18, 2016)
  • D-0918-2016 Class II — Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medic (April 18, 2016)
  • D-0920-2016 Class II — D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical (April 18, 2016)
  • D-0931-2016 Class II — Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical (April 18, 2016)
  • D-0936-2016 Class II — Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical T (April 18, 2016)
  • D-0935-2016 Class II — Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Healt (April 18, 2016)

FDA data resources