Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

Recall Insight

This FDA Drug action (record #D-1334-2022) was formally reported on August 17, 2022, with the manufacturer initiating the action on July 22, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Teva Pharmaceuticals USA Inc is listed as the recalling firm, operating out of Parsippany, NJ. Federal records indicate 4162 cartons units are affected.

The documented reason for this recall is: Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification. Distribution data in the federal record shows the product reached: Distributed in Ohio. 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.