Skip to content
Recall Observatory FDA recall evidence

Drug product

PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012

D-0204-2021

December 17, 2020

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86990
Status
Terminated
Classification
Class II
Quantity
23,029 syringes
Official record key
drug-enforcement:D-0204-2021

Official wording

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

Code information: Lot # 1220022957, BUD 1/20/2021; 1220022993, BUD 1/21/2021; 1220023020, BUD 1/14/2021; 1220023037, BUD 1/19/2021; 1220023038, BUD 1/20/2021; 1220023074, 1/24/2021; 1220023103, BUD 1/24/2021; 1220023160, BUD 1/26/2021; 1220023180, BUD 1/27/2021; 1220023183, BUD 1/27/2021; 1220023216, BUD 1/28/2021; 1220023267, BUD 2/1/2021; 1220023272, BUD 1/3/2021; 1220023344, BUD 2/10/2021; 1220023387, BUD 2/9/2021; 1220023475,BUD 2/4/2021; 1220023479, BUD 2/4/2021; 1220023564, BUD 2/9/2021; 1220023565, BUD 2/9/2021; 1220023587, BUD 2/10/2021 & 1220023624, BUD 2/11/2021.

Distribution pattern: Product was distributed to hospitals nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility