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Recall Observatory FDA recall evidence

Drug product

Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

D-0165-2018

November 16, 2017

Class II

Product summary

Firm
KRS Global Biotechnology, Inc
Event
Event 78553
Status
Terminated
Classification
Class II
Quantity
4,530 jars
Official record key
drug-enforcement:D-0165-2018

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: 06072017@22 BUD: 12/4/2017; 06222017@30 BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017

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