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Recall Observatory FDA recall evidence

Drug product

methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.

D-0070-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
7006 syringes
Official record key
drug-enforcement:D-0070-2017

Official wording

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

Code information: Lot Numbers: 15118004M, 15119082M, 15134004C, 15134006M, 15139004C, 15139011M, 15140071M, 15141001M, 15141129M, 15147012C, 15147030M, 15148004C, 15150021M, 15155002C, 15160002C, 15160006C, 151730013C, 151760016C, 151810002C, 151890129M, 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