D-0192-2018 Class II Terminated

Recalled by KRS Global Biotechnology, Inc — Boca Raton, FL

Recall Details

Product Type
Drugs
Report Date
January 17, 2018
Initiation Date
November 16, 2017
Termination Date
May 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 droptainers

Product Description

Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA, Bermuda, and New Zealand

Code Information

Lot: 06262017@31 BUD: 6/26/2018