July 10, 2019
PharMEDium Services is recalling more than 28,000 syringes containing hydromorphone hydrochloride, according to the July 10, 2019, US Food and Drug Administration (FDA) Enforcement Report. In PharMEDium’s electronic customer ordering system, the hydromorphone was listed as sulfite-free, but it actually contains sulfite.
“Serious adverse reactions could occur in patients with a sulfite allergy who are exposed to hydromorphone containing sulfites. The reactions may range from mild wheezing to severe bronchospasm and anaphylaxis,” PharMEDium stated in a July 2, 2019, news release. “To date, PharMEDium Services LLC has not received any adverse event reports related to sulfite reactions or sensitivity.”
The recall affects hydromorphone HCL in 0.9% sodium chloride, 0.5 mg per mL, 1 mL in 3-mL BD syringe (NDC 61553-352-78), from lots 190670030D, 190670031D, 190670032D, and 190670033D (Exp. 6/9/19); 190710015D, 190710016D, 190710017D, 190710018D, and 190710019D (Exp. 6/11/19); 190730028D, 190730029D, and 190730030D (Exp. 6/13/19); 190740018D (Exp. 6/16/19); 190770028D and 190770029D (Exp. 6/17/19); 190780027D, 190780028D, and 190780029D (Exp. 6/18/19); 190790030D (Exp. 6/19/19); 190800012D, 190800013D, 190800014D, 190800015D, and 190800016D (Exp. 6/20/19); 190810033D, 190810034D, 190810035D, and 190810036D (Exp. 6/23/19); 190840002D (Exp. 6/24/19); 190870008D (Exp. 6/27/19); 190910015D (Exp. 7/1/19); 190980033D (Exp. 7/8/19); 190990017D and 190990030D (Exp. 7/9/19); 191000035D (Exp. 7/10/19); 191010008D, 191010009D, and 191010010D (Exp. 7/11/19); 191050002D (Exp. 7/15/19); 191120002D (Exp. 7/22/19); 191160001D (Exp. 7/28/19); 191210020D, 191210021D, and 191210022D (Exp. 7/31/19); and 191220017D (Exp. 8/1/19).
The affected syringes were distributed within the United States.
PharMEDium voluntarily initiated the recall June 7, 2019. The FDA has not yet issued a recall classification.
Hydromorphone hydrochloride is an opioid analgesic used to treat patients with moderate to severe pain.