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Recall Observatory FDA recall evidence

Drug product

Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA

D-0071-2018

October 24, 2017

Class II

Product summary

Firm
Ace Surgical Supply Co., Inc.
Event
Event 78376
Status
Terminated
Classification
Class II
Quantity
200 vials (25 mislabeled vials)
Official record key
drug-enforcement:D-0071-2018

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag

Code information: Lot # 64340EV, exp 07/2018 ACE ITEM # 1671018

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing