OurPharma LLC — Not Yet Classified: fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag,
OurPharma LLC initiated a recall for Fentanyl Citrate 1,000 mcg/100 mL injection solution (NDC 73013-1013-01) due to a labeling discrepancy where the IV bag expiry dates and the final product expiry date did not match. A complaint received on August 31, 2026, highlighted conflicting dates of July 31, 2026, November 30, 2026, and December 9, 2026, on the same unit.
This affects OurPharma LLC, hospital pharmacy procurement teams, and quality assurance professionals responsible for compounded or pre-mixed sterile injectables.
Date discrepancies on high-alert medications like fentanyl pose significant risks to patient safety and inventory management. This suggests a potential breakdown in the reconciliation process between raw material/component labeling and finished product labeling. Regulatory teams may view this as a failure in secondary packaging controls or master batch record verification.
Verify reconciliation procedures between primary container (IV bag) expiration dates and final product labels. Conduct an immediate audit of current inventory for fentanyl citrate 1,000 mcg/100 mL to identify date discrepancies. Ensure complaint handling systems are capturing labeling inconsistencies reported from clinical settings.
Not Yet Classified. Reason: Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).. Product: fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.. Firm: OurPharma LLC (Fayetteville AR United States). Status: Ongoing.
Open in openFDA / FDA.gov