PACLITAXEL 258 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 PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL…

Recall number

D-1798-2019

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

PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL 340 MG / 500 ML NS IVPB; PACLITAXEL 332 MG / 500 ML NS IVPB; PACLITAXEL 250 MG / 500 ML NS IVPB; PACLITAXEL 117 MG / 250 ML NACL 0.9% IVPB PACLITAXEL 90 MG / 250 ML NS IVPB; PACLITAXEL 290 MG / 500 ML NS IVPB; PACLITAXEL 168 MG / 250 ML NS IVPB; PACLITAXEL 157 MG / 250 ML NS IVPB; PACLITAXEL 350 MG / 500 ML NS IVPB; PACLITAXEL 280 mg / 500 ML NS IVPB; PACLITAXEL 282 mg / 500 ML NS IVPB; PACLITAXEL 90 MG / 250 ML D5W IVPB; PACLITAXEL 255 MG / 500 ML NS IVPB; PACLITAXEL 100 MG / 250 ML NS IVPB; PACLITAXEL 80 MG / 250 ML D5W IVPB; PACLITAXEL 117 MG / 250 ML NS IVPB; PACLITAXEL 159 MG / 250 ML NS IVPB; PACLITAXEL 330 MG / 500 ML NS IVPB; PACLITAXEL135 MG / 250 ML NS IVPB; PACLITAXEL 200 MG / 500 ML NS IVPB; PACLITAXEL 150 MG / 250 ML NS IVPB; PACLITAXEL 130 MG / 250 ML NS IVPB; PACLITAXEL 144 MG / 250 ML NS IVPB; PACLITAXEL 300 MG / 500 ML NS IVPB; PACLITAXEL 120 MG / 250 ML NS IVPB; PACLITAXEL 140 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233