Enforcement Report - Week of August 25, 2021
The U.S. Food and Drug Administration is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents. Vecuronium bromide for injection 10 mg per vial and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL, 100 mg/10 mL, commonly used to provide muscle relaxation during surgery or mechanical ventilation, usually include a warning statement embossed on the vial cap to identify the product as a paralyzing agent. The following drugs are affected:
Hikma`s Generic Vecuronium Bromide Receives Approval In US
New Delhi: Indian drug majors Lupin, Sun Pharma and Glenmark Pharmaceuticals are recalling various drugs from the US market for a variety of reasons. As per the latest Enforcement Report published by the US Food and Drug Administration (USFDA), Lupin is voluntarily recalling 55,000 vials and 1,60,241 boxes of anti-bacterial drug Ceftriaxone for injection in various strengths.
Enforcement Report - Week of January 16, 2019
Sun Pharma recalls injection in US
Sun Pharmaceutical Industries Recalls Vecuronium Bromide
Aurobindo Pharma's Generic Vecuronium Bromide Receives Approval in US
Neuromuscular blocking agent containing medicines (NMBAs) are used to cause paralysis during anaesthesia.
Enforcement Report - Week of February 28, 2018