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Recall Observatory FDA recall evidence

Drug product

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612

D-0205-2021

December 17, 2020

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86990
Status
Terminated
Classification
Class II
Quantity
7,890 syringes
Official record key
drug-enforcement:D-0205-2021

Official wording

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

Code information: Lot # 1220023039, BUD 1/21/2021; 1220023080, BUD 1/24/2021; 1220023374, BUD 2/3/2021; 1220023375, BUD 2/2/2021; 1220023490, BUD 2/7/2021; 1220023554, BUD 2/8/2021 & 1220023837, BUD 2/14/2021.

Distribution pattern: Product was distributed to hospitals nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility