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July 22, 2024

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) Bags Due to an Individual Unit of Acetaminophen Overwrap Found to Have Contained a Labelled Bag of Dexmedetomidine HCL Injection (400mcg/100mL)

Summary Company Announcement Date: July 22, 2024 FDA Publish Date: July 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of Dexmedetomidine […]
July 22, 2024

Patient Medication Information (PMI)

Background FDA is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide—”Patient Medication Information” (PMI)—for prescription drug products […]
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