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Recall Observatory FDA recall evidence

Drug product

ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.

D-0055-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
9101 syringes
Official record key
drug-enforcement:D-0055-2017

Official wording

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

Code information: Lot Numbers: 15118003M, 15119077M, 15121002M, 15125019M, 15126067M, 15132022M, 15132038M, 15134043M, 15139009M, 15140006M, 15141004M, 15141065M, 15148045M, 15148070M, 151730156M, 151890125M, 151890208M, 151900010M, 151900125M, 151930044M, 151940270M, 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