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Recall Observatory FDA recall evidence

Drug product

Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

D-0178-2018

November 16, 2017

Class II

Product summary

Firm
KRS Global Biotechnology, Inc
Event
Event 78553
Status
Terminated
Classification
Class II
Quantity
2,274 vials
Official record key
drug-enforcement:D-0178-2018

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Code information: Lots: 06082017@33 BUD: 12/5/2017; 06152017@4 BUD: 12/12/2017; 07272017@4 BUD: 1/23/2018; 10042017@22 BUD: 4/2/2018; 09282017@3 BUD: 3/27/2018

Distribution pattern: Nationwide in the USA, Bermuda, and New Zealand

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing