Drug & medication recalls Moderate risk

AZACITIDINE 125 MG / SUB-Q SYRINGE 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 AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, R…
Recall number
D-1751-2019
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

AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

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