Home / Recalls / Infusion Options, Inc. / D-1815-2019

D-1815-2019 Class II Terminated

Recalled by Infusion Options, Inc. — Brooklyn, NY

Recall Details

Product Type
Drugs
Report Date
August 21, 2019
Initiation Date
June 12, 2019
Termination Date
March 21, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG / 250 ML NS IVPB; TRASTUZUMAB 444 MG / 250 ml NS IVPB; TRASTUZUMAB 634 MG / 250 ML NS IVPB; TRASTUZUMAB 330 MG / 250 ML NS IVPB; TRASTUZUMAB 781 MG / 250 ML NS IVPB; TRASTUZUMAB 376 mg / 250 ML NS IVPB; TRASTUZUMAB 114 MG / 250 ML NS IVPB; TRASTUZUMAB 266 MG / 250 ML NS IVPB TRASTUZUMAB 323 MG / 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

NY only

Code Information

All lots within expiry

Other recalls by Infusion Options, Inc.

  • D-1744-2019 Class II — Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusi (June 12, 2019)
  • D-1819-2019 Class II — FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 1 (June 12, 2019)
  • D-1773-2019 Class II — ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave (June 12, 2019)
  • D-1807-2019 Class II — RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; Rx O (June 12, 2019)
  • D-1788-2019 Class II — IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the (June 12, 2019)
  • D-1801-2019 Class II — PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13th (June 12, 2019)
  • D-1812-2019 Class II — Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G, Ma (June 12, 2019)
  • D-1764-2019 Class II — DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 ML NS IVPB, Rx (June 12, 2019)
  • D-1810-2019 Class II — RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL IV (June 12, 2019)
  • D-1781-2019 Class II — Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; (June 12, 2019)