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Recall Observatory FDA recall evidence

Drug product

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.

D-0089-2017

July 17, 2015

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 73925
Status
Terminated
Classification
Class II
Quantity
6970 syringes
Official record key
drug-enforcement:D-0089-2017

Official wording

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

Code information: Lot Numbers: 151120168M, 151120169M, 15112027M, 15112096M, 15113021M, 15113080M, 15113081M, 15113082M, 15113083M, 15113084M, 15113085M, 15113086M, 15113087M, 15113088M, 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