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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 a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.

D-0051-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
4860 syringes
Official record key
drug-enforcement:D-0051-2017

Official wording

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Code information: Lot Numbers: 15121069M, 15124075M, 15126078M, 15138012M, 15138013M, 15148077M, 15149122M, 15150103M, 151740201M, 151880159M, 151890210M, Exp between 07/15/15-10/12/15

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    loss of potency