PharMEDium Recalls Hydromorphone Syringes Due to Sulfite Mislabeling

Plain-English summary

PharMEDium Services, LLC is recalling 28,140 syringes of Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe. The recall was initiated because the product is labeled as sulfite-free, but it is produced with a raw material that contains sulfite.

The affected product is distributed nationwide within the United States. The recall covers specific lots with expiration dates ranging from June 9, 2019, to August 1, 2019. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

Consumers and healthcare providers should stop using the affected syringes and contact PharMEDium Services or their healthcare provider for further instructions. Patients with sulfite sensitivity should be particularly cautious and consult their healthcare provider regarding alternative treatments.

The recalled product

Product

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78

Manufacturer

PharMEDium Services, LLC

Category

Drug — Injectable Medication

Hazard

• sulfite-mislabeling
• allergen-sulfite

Affected units

28,140

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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