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Recall Observatory FDA recall evidence

Drug product

Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

D-0896-2018

June 14, 2018

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 80303
Status
Terminated
Classification
Class II
Quantity
179 bags
Official record key
drug-enforcement:D-0896-2018

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 # 20180327@27, 20180327@40, 20180328@9, Exp 06/28/2018

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