Drug used to bring blood pressure back up after surgery is recalled. It may not be sterile.
A drug used to bring a person’s blood pressure back up after anesthesia is being recalled because it may not be sterile.
Sagent Pharmaceuticals announced its nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL), on Thursday, the U.S. Food and Drug Administration announced.
Why the drug was recalled
This drug, manufactured by Indoco Remedies Ltd., distributed by Sagent Pharmaceuticals and packaged in 3 mL glass tubular vials, was recalled after a customer complained about a potentially loose, crimped vial overseal. If an overseal is loose or otherwise compromised, it could allow contaminants to come into contact with the drug, which, in some cases, could lead to infections or even be fatal.
“The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated,” the FDA said in its notice. Sagent has not received any reports of anyone getting sick from the use of the phenylephrine.
Phenylephrine hydrochloride is used to bring low blood pressure (hypotension) back up after surgery, according to the Mayo Clinic.
What to look for on the package
The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide from Nov. 17, 2020, to March 8, 2021, according to the FDA.
The lot numbers are: PHT8IB2, PHT9IB2 and PHT1JB2.
In addition to the alert, customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for the return of all of the recalled phenylephrine hydrochloride product, according to Sagent, which has headquarters in Illinois.
More information on the recall is available at www.Sagentpharma.com.
Customers can also call Sagent’s customer call center at 866-625-1618 from 8 a.m. to 7 p.m. central time Monday-Friday.
Healthcare workers who have medical questions about phenylephrine hydrochloride Injection can call Medical Affairs at 866-625-1618 and choose option 3 from 8 a.m. to 5 p.m. Monday-Friday central time.
Consumers can also contact their physician or healthcare provider if they have experienced any problems related to the drug’s use.
If this drug sounds familiar
In an unrelated recall, in January, one lot of surgical drug cisatracurium besylate got recalled by Meitheal Pharmaceuticals because some of it was put in bottles labeled as phenylephrine hydrochloride.
The two drugs have almost opposite functions. Basically, cisatracurium brings the muscles down, phenylephrine brings the blood pressure up.
Miami Herald staff writer David J. Neal contributed to this story.
