Acetaminophen Injection 1 recalled over labeling errors

Recall date

July 22, 2024

Source

U.S. Food & Drug Administration (FDA) — recall announcement

Official notice title

Hikma Pharmaceuticals PLC recalls Hikma — Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL

Brand / firm

Hikma Pharmaceuticals PLC, Hikma

Why it was recalled

Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). — Mislabeling

What was recalled

Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL