Sterility Concerns with Phenylephrine HCI Injection Prompt Recall

Administration of compromised products may result in serious or potentially life-threatening infections
Administration of compromised products may result in serious or potentially life-threatening infections

Sandoz announced a voluntary recall of four lots of Phenylephrine HCI Injection, USP, 10mg/mL, 5mL and 10mL vials due to concerns of product sterility during an inspection at Allergy Laboratories, Inc. While there have been no reported illnesses or injuries, administration of compromised sterile products may result in serious or potentially life-threatening infections or death. 

Phenylephrine HCl is a selective α1-adrenergic receptor agonist intended for the maintenance of an adequate level of blood pressure during spinal and 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.  

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The Lot numbers affected were #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.

For more information call (800) 525-8747 or visit Sandoz.com.

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