Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

Recall Insight

This FDA Drug action (record #D-1184-2018) was formally reported on September 19, 2018, with the manufacturer initiating the action on August 28, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Pfizer Inc. is listed as the recalling firm, operating out of New York, NY. Federal records indicate 1,580 vials units are affected.

The documented reason for this recall is: Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point Distribution data in the federal record shows the product reached: Nationwide USA. 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 8 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.