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D-0532-2016 Class II Terminated

Recalled by Walgreens Infusion Services — San Antonio, TX

FDA drug recall D-0532-2016 was initiated by Walgreens Infusion Services on November 10, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated October 18, 2017). Affected quantity: 40 Minibags.

Recall Details

Product Type
Drugs
Report Date
January 6, 2016
Initiation Date
November 10, 2015
Termination Date
October 18, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 Minibags

Product Description

Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Texas

Code Information

All lots within expiry.

Other recalls by Walgreens Infusion Services

  • D-0546-2016 Class II — Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded b (November 10, 2015)
  • D-0551-2016 Class II — Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San An (November 10, 2015)
  • D-0544-2016 Class II — Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) (November 10, 2015)
  • D-0531-2016 Class II — L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San A (November 10, 2015)
  • D-0549-2016 Class II — Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compou (November 10, 2015)
  • D-0540-2016 Class II — IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Ant (November 10, 2015)
  • D-0536-2016 Class II — Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, Sa (November 10, 2015)
  • D-0537-2016 Class II — Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 1 (November 10, 2015)
  • D-0558-2016 Class II — 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Ca (November 10, 2015)
  • D-0542-2016 Class II — Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Anto (November 10, 2015)

FDA data resources