REGULATORY INTELLIGENCE·Recall
Hikma Injectables USA Inc. Initiates Nationwide Fentanyl Recall Over Barcode Labeling Error
Hikma Injectables USA Inc. has completed a nationwide Class III recall of 1,895 bags of Fentanyl 1000mcg/100mL Injection due to a wrong barcode on the labeling. This voluntary, firm-initiated action highlights critical quality control vulnerabilities in pharmaceutical packaging, posing risks to patient safety and supply chain integrity for this Schedule II controlled substance.
90-Day Activity
Hikma Injectables USAWater For Injection
MKMeera Krishnan· Senior Regulatory Intelligence Analyst2024-05-08