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Recall Observatory FDA recall evidence

Drug product

ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.

D-0056-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
12,173 syringes
Official record key
drug-enforcement:D-0056-2017

Official wording

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

Code information: Lot Numbers: 15117083M, 15117090M, 15118047M, 15121052M, 15124079M, 15126020M, 15127007M, 15127096M, 15133014M, 15133068M, 15134067M, 15139089M, 15140069M, 15141027M, 15141043M, 15142095M, 15146008M, 15149111M, 15149116M, 151730004M, 151730116M, 151880152M, 151890126M, 151930170M, 151940024M, 151940182M, 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