Skip to content
Recall Observatory FDA recall evidence

Drug product

Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

D-0167-2018

November 16, 2017

Class II

Product summary

Firm
KRS Global Biotechnology, Inc
Event
Event 78553
Status
Terminated
Classification
Class II
Quantity
3,280 jars
Official record key
drug-enforcement:D-0167-2018

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@38 BUD: 12/4/2017; 07062017@48 BUD: 1/2/2018; 08012017@23 BUD: 1/28/2018; 08212017@36 BUD: 2/17/2018; 09182017@26 BUD: 3/17/2018

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