Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82

Recall Insight

This FDA Drug action (record #D-0444-2023) was formally reported on March 15, 2023, with the manufacturer initiating the action on February 21, 2023. It is classified under Moderate severity (Class II), with a current status of Terminated. Denver Solutions, LLC DBA Leiters Health is listed as the recalling firm, operating out of Englewood, CO. Federal records indicate 1212 units units are affected.

The documented reason for this recall is: CGMP DEVIATIONS Distribution data in the federal record shows the product reached: Nationwide within the United States including VA or other Government facilities. 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 3 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.