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Recall Observatory FDA recall evidence

Drug product

Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16

D-0965-2015

February 24, 2015

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 70583
Status
Terminated
Classification
Class II
Quantity
421 syringes
Official record key
drug-enforcement:D-0965-2015

Official wording

Reason: Presence of particulate.

Code information: Lot: 20141223@20

Distribution pattern: IN, AR, MO, MN

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate