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Surgical Muscle Relaxant Pulled in Class I Recall

January 18, 2019

Glass particulate found in vials has caused Sun Pharmaceuticals to recall four lots of vecuronium bromide for injection, according to the January 16, 2019, US Food and Drug Administration (FDA) Enforcement Report. The FDA declared the recall Class I, signaling use of the affected vials could cause serious health problems or death.

The recall is for the following products, which were distributed throughout the United States:

  • vecuronium bromide for injection 10 mg, 1 mg/mL when reconstituted to 10 mL lyophilized, 10 x 10-mg vials (vial NDC 47335-931-40, carton NDC 47335-931-44) from lots JKS0443A, JKS0444A, and JKS0477A (Exp. 3/19); and
  • vecuronium bromide for injection 20 mg, 1 mg/mL when reconstituted to 20 mL lyophilized, 10 x 20-mg vials (vial NDC 47335-932-40, carton NDC 47335-932-44) from lot JKS0400A (Exp. 3/19).

Sun Pharmaceuticals initiated the voluntary recall January 3, 2019. The FDA designated the recall Class I January 14, 2019.

Vecuronium bromide for injection is a prescription muscle relaxant administered prior to general anesthesia before surgery.

Jolynn Tumolo

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