Gemcitabine 1910 MG / NS IVPB recalled over sterility concerns

Recall date

June 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Infusion Options, Inc. recalls Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; G…

Recall number

D-1781-2019

FDA classification

Class II

Brand / firm

Infusion Options, Inc.

Sold / distributed

NY only

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine 1748 MG / 250 ML NS IVPB; Gemcitabine 890 MG /250 ML NS IVPB Gemcitabine 2000 MG /250 ML 0.9% NACL IVPB; Gemcitabine 660 MG / 250 ML NS IVPB; Gemcitabine 1880 MG /250 ML NS IVPB; Gemcitabine 1180 MG / 250 ML NS IVPB; Gemcitabine 1400 MG / 250 ML NS IVPB Gemcitabine 1300 MG / 250 ML NS IVPB; Gemcitabine 1406 MG /250 ML NS IVPB; Gemcitabine 1672 MG / 250 ML NS IVPB; Gemcitabine 2050 MG / 250 ML NS IVPB; Gemcitabine 1260 MG / 250 ML NS IVPB; Gemcitabine 1710 MG / 250 ML NS IVPB; Gemcitabine 1320 MG / 250 ML NS IVPB; Gemcitabine 1200 MG /250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233