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Blood Pressure Solution Pulled


July 13, 2018

SCA Pharmaceuticals is voluntarily recalling numerous lots of 250-mL bags of norepinephrine bitartrate solution due to sterility concerns, according to the July 11, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The following formulations and lots are included in the recall:

  • 2268 bags of norepinephrine bitartrate 4 mg (16 mcg/mL) in 0.9% sodium chloride from lots 1218000928, 1218000944, 1218000945, 1218001075, 1218001076, and (Exp. 6/19/18 through 7/3/18);
  • 1882 bags of norepinephrine bitartrate 8 mg (32 mcg/mL) in 0.9% sodium chloride from lots 1218000930, 1218000946, 1218001058, 1218001077, 1218001169, 1218001170, 1218001190, 1218001191, 1218001206, and 1218001317 (Exp. 6/18/18 through 7/11/18); and
  • 1397 bags of norepinephrine bitartrate 16 mg (64 mcg/mL) in 0.9% sodium chloride from lots 1218000677, 1218000947, 1218000982, 1218001018, 1218001029, 1218001059, 1218001060, 1218001078, 1218001079, 1218001171, 1218001172, 1218001192, 1218001193, 1218001207, 1218001209, and 1218001210 (Exp. 6/19/18 through 7/3/18).

The affected products were distributed across the United States.

SCA Pharmaceuticals initiated the recall June 14, 2018. On July 2, 2018, the FDA designated the recall Class II, indicating use of the bags could cause temporary or medically reversable harm. A potential for serious harm also exists, although the likelihood is remote.

Norepinephrine bitartrate is used to increase blood pressure and blood glucose in patients with life-threatening low blood pressure caused by various medical conditions and surgical procedures.

Jolynn Tumolo


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