PEMETREXED 910 MG QS 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 PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000 mg QS 100 ml 0.9% NACL IVPB;…

Recall number

D-1803-2019

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

PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000 mg QS 100 ml 0.9% NACL IVPB; PEMETREXED 490 MG /100 ml NS IVPB; PEMETREXED 800 mg/ 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233