Skip to main content
News

Hypotension Drug Recalled


July 13, 2018

Sterility concerns have prompted SCA Pharmaceuticals to issue a voluntary recall of several lots of phenylephrine HCL bags.

According to the July 11, 2018, US Food and Drug Administration (FDA) Enforcement Report, the following products and lots are included in the recall:

  • phenylephrine HCL 80 mg in 0.9% sodium chloride, 250-mL bag (320 mcg/mL), from lot 20180328@25 (Exp. 6/26/18);
  • phenylephrine HCL 50 mg in 0.9% sodium chloride, 250-mL bag (200 mcg/mL), from lot 20180329@2 (Exp. 6/27/18);
  • phenylephrine HCL 40 mg in 0.9% sodium chloride, 250-mL bag (160 mcg/mL), from lot 20180323@24 (no expiration date provided);
  • phenylephrine HCL 20 mg in 0.9% sodium chloride, 250-mL bag (160 mcg/mL), from lot 20180323@29 (Exp. 6/21/18); and
  • phenylephrine HCL 10 mg in 0.9% sodium chloride, 250-mL bag (40 mcg/mL), from lot 20180323@24 (Exp. 6/21/18).

The affected phenylephrine HCL bags were distributed across the United States.

On July 2, 2018, the FDA designated the recall, which was initiated by SCA Pharmaceuticals June 14, 2018, a Class II recall. The classification communicates use of the affected bags may cause temporary or medically reversable harm. While remote, the potential for serious harm also exists.

Phenylephrine is used to increase blood pressure in patients with clinically important hypotension caused by anesthesia, septic shock, or other factors.

Jolynn Tumolo


For more Pharmacy Learning Network articles, visit the homepage

To learn about Pharmacy Learning Network Live meetings, click here

Back to Top