FDA-Drug2019-07-10Class I

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

PharMEDium Services, LLC
Hazard

Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

Sold states
Nationwide within the United States
Affected count
28,140 syringes
Manufactured in
36 Stults Rd, N/A, Dayton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1488-2019

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