RecallRadar

FDA Drug recall D-0734-2021

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc

On 2021-08-25 the FDA classified a Class II recall of Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc by Teva Pharmaceuticals Usa, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0734-2021
ClassificationClass II
Statusterminated
Initiated2021-07-29
Published2021-08-25
Last updated2026-09-13 11:52 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

Product

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot #: 31328668B, exp. date 04/2023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0734-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.