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Recall Observatory FDA recall evidence

Drug product

neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.

D-0082-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
21053 syringes
Official record key
drug-enforcement:D-0082-2017

Official wording

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

Code information: Lot Numbers: 15112030M, 15112033M, 15112034M, 15112099M, 15112101M, 15112103M, 15112105M, 15112108M, 15113001M, 15113002M, 15113003M, 15113007M, 15113032M, 15113033M, 15113075M, 15113076M, 15159002S, 15159003S, 15159004S, 15159006S, 15159007S, 15159009S, 15159011S, 15174213S, 15175035S, 15175036S, 15175037S, 15176015S, 15176016S, 15176017S, 15176018S, 15176020S, 15176021S, 15176022S, 15176024S, 15177011S, 15177012S, 15177013S, 15177016S, 15177017S, 15177018S, 15177019S, 15180245S, 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