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Recall Observatory FDA recall evidence

Drug product

Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309

D-0200-2021

December 17, 2020

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86990
Status
Terminated
Classification
Class II
Quantity
7,275 syringes
Official record key
drug-enforcement:D-0200-2021

Official wording

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Code information: Lot # 1220023034, BUD 1/19/2021; 1220023088, BUD 1/24/2021; 1220023112, BUD 1/25/2021; 1220023288, BUD 1/31/2021; 1220023323, BUD 2/2/2021; 1220023539, BUD 2/8/2021 & 1220023613, BUD 2/10/2021.

Distribution pattern: Product was distributed to hospitals nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility