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Recall Observatory FDA recall evidence

Drug product

midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351.

D-0074-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
4058 syringes
Official record key
drug-enforcement:D-0074-2017

Official wording

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

Code information: Lot Numbers: 15124077M, 15126077M, 15128005M, 15131033M, 15133007C, 15133080M, 15135013C, 15138066M, 15139013C, 15141044M, 15154009C, 15160005C, 151740043C, 151800047C, 151900147M, 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