fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02

Recall Insight

This FDA Drug action (record #D-1553-2014) was formally reported on August 27, 2014, with the manufacturer initiating the action on June 27, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Healix Infusion Therapy, Inc. is listed as the recalling firm, operating out of Sugar Land, TX. Federal records indicate 12 bags units are affected.

The documented reason for this recall is: Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Distribution data in the federal record shows the product reached: Texas and Georgia. 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 12 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.