Santos is recalling four lots of phenylephrine HCl Injection, USP, 10mg/mL, 5mL and 10mL vials due to sterility concerns that arose during a recent inspection at Allergy Laboratories, Inc., where the drug is manufactured. Administration of a compromised sterile product could result in serious or potentially life-threatening infections or death. No illnesses or injuries have been reported to date.
Phenylephrine HCl is a selective α1-adrenergic receptor agonist that is used to maintain adequate blood pressure in patients during spinal inhalation anesthesia and for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension or hypersensitivity. Phenylephrine HCl is also used to overcome paroxysmal supraventricular tachycardia, to prolong spinal anesthesia, and as a vasoconstrictor in regional analgesia.
Affected Lot numbers include #091914 (25 unit pack), #080114, #090414, #092614 and were packaged with the corresponding expiration dates; 09/2016, 08/2016, 09/2016 and 09/2016. The recalled lots were distributed September 2014 and February 2015.
Any adverse events or side effects related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.