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Recall Observatory FDA recall evidence

Drug product

HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ

D-0854-2018

June 05, 2018

Class II

Product summary

Firm
PharMEDium Services, LLC
Event
Event 80251
Status
Terminated
Classification
Class II
Quantity
2,800 syringes
Official record key
drug-enforcement:D-0854-2018

Official wording

Reason: Superpotent and Subpotent

Code information: Lot numbers: 180820005D, exp 6/21/2018; 180990007D, exp 7/8/2018; and 181000020D, exp 7/9/2018

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent