Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.

Recall Insight

This FDA Drug action (record #D-1325-2022) was formally reported on August 17, 2022, with the manufacturer initiating the action on June 29, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Mckesson Medical-Surgical Inc. Corporate Office is listed as the recalling firm, operating out of Richmond, VA. Federal records indicate 23 cartons units are affected.

The documented reason for this recall is: CGMP Deviations: products were stored outside the drug label specifications. Distribution data in the federal record shows the product reached: Nationwide in the 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 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.