IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

Recall Insight

This FDA Drug action (record #D-0765-2022) was formally reported on April 20, 2022, with the manufacturer initiating the action on March 29, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Teva Pharmaceuticals USA Inc is listed as the recalling firm, operating out of Parsippany, NJ. Federal records indicate 1565 vials units are affected.

The documented reason for this recall is: Presence of Particulate Matter: Product was found to contain silica and iron oxide Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.