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Recall Observatory FDA recall evidence

Drug product

Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

D-0895-2018

June 14, 2018

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 80303
Status
Terminated
Classification
Class II
Quantity
492 bags
Official record key
drug-enforcement:D-0895-2018

Official wording

Reason: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

Code information: Lot # 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, Exp 6/26/2018

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility