PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: July 10, 2019 Initiated: June 7, 2019 #D-1488-2019

Product Description

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

Reason for Recall

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

Details

Recalling Firm
PharMEDium Services, LLC
Units Affected
28,140 syringes
Distribution
Nationwide within the United States
Location
Dayton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by PharMEDium Services, LLC. Units affected: 28,140 syringes.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Drug on July 10, 2019. Severity: Critical. Recall number: D-1488-2019.