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Recall Observatory FDA recall evidence

Drug product

ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412

D-0189-2021

December 17, 2020

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86990
Status
Terminated
Classification
Class II
Quantity
7,257 syringes
Official record key
drug-enforcement:D-0189-2021

Official wording

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

Code information: Lot # 1220022996, BUD 1/21/2021; 1220023017, BUD 1/20/2021; 1220023021, BUD 1/17/2021; 1220023033, BUD 1/19/2021; 1220023146, BUD 1/26/2021; 1220023189, BUD 1/27/2021 1220023242, BUD 1/25/2021; 1220023321, BUD 2/2/2021; 1220023357 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