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Recall Observatory FDA recall evidence

Drug product

methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.

D-0072-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
7556 syringes
Official record key
drug-enforcement:D-0072-2017

Official wording

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

Code information: Lot Numbers: 15118069M, 15126004M, 151320095M, 15132023M, 15133005C, 15133011M, 15133032M, 15140003C, 15141005C, 15153010C, 151390098M, 15139065M, 15140074M, 151450122M, 15146010M, 15147052M, 15148046M, 15148058M, 15152062M,15160001C, 151680006C, 151720023M, 151720080M, 151730133M, 151740008C, 151740211M, 151800043C, 151880168M, 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