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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, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.

D-0077-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
935 syringes
Official record key
drug-enforcement:D-0077-2017

Official wording

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

Code information: Lot Numbers: 15117038M, 151200111M, 15126052M, 15127038M, 15131015M, 15134028M, 15134031M, 15135049M, 151380104M, 15139033M, 15139063M, 151410121M, 15146038M, 15147041M, 15149045M, 15152036M, 151730212M, 151890291M, 151930131M, 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