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Recall Observatory FDA recall evidence

Drug product

morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.

D-0076-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
3270 syringes
Official record key
drug-enforcement:D-0076-2017

Official wording

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

Code information: Lot Numbers: 15121035M, 15125026M, 15126061M, 15132040M, 15133041M, 15139084M, 15147038M, 15148024M, 15152044M, 151740022M, 151900205M, 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