Skip to content
Recall Observatory FDA recall evidence

Drug product

Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012

D-0197-2021

December 17, 2020

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86990
Status
Terminated
Classification
Class II
Quantity
11,075 syringes
Official record key
drug-enforcement:D-0197-2021

Official wording

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

Code information: a) Lot # 1220023076, BUD 1/24/2021 & 1220023549, BUD 2/9/2021. b) Lot # 1220023040, BUD 1/19/2021; 1220023070, BUD 1/21/2021; 1220023105, BUD 1/25/2021; 1220023158, BUD 1/26/2021; 1220023315, BUD 2/1/2021; 1220023342, BUD 2/2/2021; 1220023431, BUD 2/4/2021; 1220023471, BUD 2/3/2021; 1220023481, BUD 2/4/2021 & 1220023509, BUD 2/8/2021.

Distribution pattern: Product was distributed to hospitals nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility