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Multiple Pain Killers Pulled


July 27, 2018

Single-dose bags, syringes, and cassettes containing fentanyl and hydromorphone are being pulled by Avella of Deer Valley Inc. because of the potential for leakage, according to the July 25, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects:

  • fentanyl 2 mcg/mL, 0.125% ropivacaine, fentanyl citrate 300 mcg, ropivacaine HCL PF, 187.5 mg, 0.9% sodium chloride QS 150 mL, 150-mL single-dose cassettes (NDC 15082-278-86) from lot 5/14/18 1012 172-27886Y (BUD 6/28/18);
  • fentanyl 3 mcg/mL, 0.1% bupivacaine, fentanyl citrate 750 mcg, bupivacaine HCL PF, 250 mg, 0.9% sodium chloride, QS 250 mL, 250mL single-dose cassettes (NDC 15082-250-87) from lot 5/14/18 0913 320-25087Y (BUD 6/28/18);
  • fentanyl 5 mcg citrate, 5 mcg in 0.9% sodium chloride, QS 0.5 mL (10 mcg per mL) 5 mcg in 0.5 mL, 0.5-mL single-dose syringes (NDC 15082-210-72) from lot 5/24/18 0502 149-21072S (BUD 8/22/18);
  • hydromorphone 1 mg/mL (hydromorphone HCL 30 mg, 0.9% sodium chloride QS 30 mL) 30-mL single-dose syringes (NDC 42852-222-63) from lot 3/15/18 0954 22263M (BUD 6/13/18); and
  • hydromorphone 0.2 mg/mL (hydromorphone HCL 20 mg, 0.9% sodium chloride QS 100 mL), 100-mL single-dose bags (NDC 15082-221-10) from lots 4/26/18 0520 22110P (BUD 8/9/18) and 5/14/18 1350 22110P (BUD 8/27/18).

The affected 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. The designation signals use of the products could cause a temporary health problem. The likelihood of serious harm is remote.

Fentanyl and hydromorphone are narcotic analgesic medications.

Jolynn Tumolo


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