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Recall Observatory FDA recall evidence

Drug product

Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09

D-0620-2020

November 26, 2019

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 84326
Status
Terminated
Classification
Class II
Quantity
1363 syringes
Official record key
drug-enforcement:D-0620-2020

Official wording

Reason: Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).

Code information: 1219012595 29-Dec-19 1219012647 01-Jan-20

Distribution pattern: nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance