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Blood Pressure Med Recalled


July 27, 2018

Citing a potential for leakage, Avella of Deer Valley Inc. is recalling single-dose bags and syringes of norepinephrine, according to the July 25, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 5 formulations:

  • norepinephrine bitartrate 4 mg added to 5% dextrose 250 mL (concentration 16 mcg/mL), volume 254-mL single-dose bags (NDC 42852-807-25) from lots 4/30/18 2471 80725P (BUD 6/29/18), 5/1/18 1240 80725P (BUD 6/30/18), and 5/8/18 1111 80725P (BUD 7/7/18);
  • norepinephrine bitartrate 4 mg added to 0.9% sodium chloride 250 mL, 254-mL single-dose bags (NDC 42852-860-25) from lots 5/14/18 1330 86025P (BUD 7/8/18) and 5/24/18 2314 86025P (BUD 7/18/2018);
  • norepinephrine bitartrate 8 mg added to 5% dextrose 250 mL (concentration 32 mcg/mL), 258-mL single-dose bags (NDC 42852-815-25) from lots 4/23/18 0101 81525P and 4/23/18 1020 81525P (BUD 6/22/18), 4/30/18 1123 81525P and 4/30/18 1311 81525P (BUD 6/29/18), 5/1/18 3456 81525P (BUD 6/30/18), and 5/8/18 3213 81525P (BUD 7/7/18);
  • norepinephrine bitartrate 16 mg, 5% dextrose 250 mL, 266-mL single-dose bags (NDC 42852-834-25) from lots 4/26/18 0515 83425P (BUD 6/25/18) and 4/24/18 1332 83425P (BUD 6/23/2018); and
  • norepinephrine bitartrate 160 mcg in 5% dextrose QS 10 mL. 10-mL single-dose syringes (NDC 42852-807-61) from lots 5/7/18 0301 2-80761S (BUD 6/21/18), 5/9/18 0510 2-80761S (BUD 6/23/18), and 5/21/18 1807 80761S (BUD 7/15/18).

The products were distributed throughout the United States.

Avella of Deer Valley voluntarily initiated the recall June 12, 2018. The FDA designated the recall Class II July 19, 2018. Under Class II recalls, use of the affected products cause temporary health problems, although the likelihood of serious harm is remote.

Norepinephrine is used to treat patients with life-threatening low blood pressure.

Jolynn Tumolo


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