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Recall Observatory FDA recall evidence

Drug product

SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29

D-0059-2018

October 19, 2017

Class II

Product summary

Firm
SCA Pharmaceuticals, LLC
Event
Event 78320
Status
Terminated
Classification
Class II
Quantity
1248 syringes
Official record key
drug-enforcement:D-0059-2018

Official wording

Reason: Lack Of Assurance Of Sterility.

Code information: Lot: 20170726@35 BUD: 10/24/2017

Distribution pattern: Nationwide in the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack Of Assurance Of Sterility