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Recall Observatory FDA recall evidence

Drug product

Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006

D-0186-2021

December 17, 2020

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86990
Status
Terminated
Classification
Class II
Quantity
1,930 syringes
Official record key
drug-enforcement:D-0186-2021

Official wording

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

Code information: Lot # 1220023001, BUD 2/5/2021; 1220023126, BUD 2/9/2021 & 1220023606, BUD 2/25/2021.

Distribution pattern: Product was distributed to hospitals nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility