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Recall Observatory FDA recall evidence

Drug product

fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40

D-1009-2017

July 14, 2017

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 77770
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1009-2017

Official wording

Reason: Lack of Assurance of Sterility; product has the potential to leak.

Code information: Lots: 20170502@18 BUD: 7/31/2017; 20170502@39 BUD: 7/31/2017; 20170502@62 BUD: 7/31/2017; 20170503@22 BUD: 8/1/2017; 20170503@4 BUD: 8/1/2017; 20170503@54 BUD: 8/1/2017; 20170504@10 BUD: 8/2/2017; 20170505@15 BUD: 8/3/2017; 20170506@23 BUD: 8/4/2017

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility